Essential Responsibilities

• Works closely with Manufacturing and Automation Engineering to create, update, and maintain equipment User Requirements Specifications.
• Support design, fabrication, and upgrades for manufacturing equipment as directed by Automation Engineering Manager.
• Troubleshooting and corrective actions to support equipment issues. Provide guidance and training for maintenance technicians and operations on related activities.
• Works closely with Automation Engineering Manager and PLC Engineer to facilitate machine upgrades and modifications.
• Works with Manufacturing and Maintenance to maintain accuracy, location, and completion of equipment manual, work instructions, and log books.
• Provide guidance on machine maintenance requirements.
• Ability to collect data from multiple sources and propose prioritization to fix, standardize, and incorporate new capabilities for manufacturing equipment.
• Project technical lead, with responsibility for project management activities.
• Work with outside vendors and consultants.
• Draft specifications for mechanical, electrical, and control components.
• Support new company initiatives in the areas of Manufacturing and Operations.
• Support compliance with FDA, ISO, OSHA, and all other regulatory requirements in compliance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Electrical, Automation, Robotics, Mechanical, or Computer engineering, or equivalent education and experience.
• Five or more years’ experience in Engineering with strong automation design and troubleshooting responsibilities.
• Experience with eMaint CMMS is preferred.
• Experience with SolidWorks is preferred.
• Experience with electrical wiring.
• Experience with technical writing.
• Experience in PLC logic and programming is desirable.
• Experience in a FDA regulated manufacturing facility preferred.
• Good communication and interpersonal skills.
• Good analytical skills.
• Ability to work both independently with little direction, and as a member of a team.
• Ability to manage several projects at once to meet established timelines is essential.
• Proficient in Microsoft Office products.
• Proven ability to develop and implement standard engineering practices, as well as provide detailed documentation upon completion.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Frequently required to stoop or bend.
• Regularly required to lift and/or move up to 20 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Fine motor control to grasp and manipulate objects.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Works on a production line packaging products, following written guidelines and specifications for each product.
• Independently operates production machinery after the successful completion of training and certification.
• Follows established quality requirements for each product.
• Adheres to all safety policies and procedures for operating equipment and handling raw materials and finished goods.
• Cross train to other work stations to enable rotation of work.
• Adheres to all company policies and procedures.
• Maintains good housekeeping and a clean work area.
• Promotes teamwork by working with others to achieve production efficiency, quality, and on-time delivery goals.
• Regular attendance is an essential function of this position
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adheres to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Prior experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Prior experience working on a production line preferred.
• Ability to read and interpret written policies and procedures.
• Ability to complete paperwork correctly.
• Ability to add, subtract, multiply and count.
• Good written and verbal communication skills.
• Ability to work with others to achieve goals.
• Ability to perform repetitive tasks.
• Ability to recognize good quality and perform to quality standards.

PHYSICAL REQUIREMENTS:

• Varied position throughout shift, including standing and/or sitting for up to 2 hours at a time.
• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Frequently required to lift and/or move up to 25 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Good manual dexterity.
• Ability to grasp small objects.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Responsible for the receipt, storage, and shipping of raw materials, finished goods, and other supplies to support company operations.

• Unloads trucks, as needed; checks in product, matches purchase orders to product, and distributes to appropriate person/department.

• Processes shipping orders or requisitions, as requested, ensuring shipping timelines are met and the most cost-effective shipping method is used.

• Moves raw materials and other incoming items to designated areas for processing.

• Moves finished goods to designated shipping areas.  Loads trucks for shipping as needed.

• Marks materials with identifying information as required, in compliance with current Good Manufacturing Practices (GMP) regulations.

• Records amounts of materials or items received or distributed in the inventory control system.

• Sorts and places materials or items on racks, shelves, or in bins, according to product code.

• Ensures warehouse is safe and accessible for all employees.

• Assists with physical inventories, ensuring the accuracy of counts. 

• Maintains inventory levels within the warehouse as directed.

• Keeps the warehouse organized and orderly at all times.

• Transports raw materials, finished goods, and other items between the Sandpoint, Idaho, and Liberty Lake, Washington, warehouses. 

• Ensure compliance GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.

• Adheres to company safety requirements.

• Regular attendance.

• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Prior experience in a warehouse/distribution setting.

• High school diploma or equivalent.

• Forklift certified.

• Ability to work independently with little direction.

• Ability to read and interpret documents such as procedure manuals.

• Ability to perform basic math skills, including addition and subtraction.

• Ability to complete paperwork.

• Proficient with Microsoft Office products.

• Excellent interpersonal skills with the ability to communicate effectively at all levels within the organization, and with customers and vendors.

• Valid driver’s license, good driving record, and proof of auto insurance coverage.

• Ability to obtain medical card.

• Ability to drive 26’ straight truck, 26,000 gross.

• Basic computer skills, Microsoft Suite.

• Prior experience in a FDA regulated manufacturing facility preferred.

• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Occasionally required to sit.

• Frequently required to talk or hear.

• Frequently required to stand or walk.

• Occasionally required to climb or squat.

• Frequently required to move and/or lift up to 25 pounds.

• Occasionally required to move and/or lift up to 50 pounds.

• Vision ability includes close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Schedule and perform preventive maintenance on electrical, heating, ventilation, plant systems and air conditioning (HVAC) equipment.
• Schedule and perform preventive maintenance on mechanical and plumbing equipment.
• Diagnose mechanical, electrical and plumbing problems and make necessary repairs.
• Maintain the facility, keeping it free from safety hazards for employees and visitors.
• Perform general facility maintenance and repairs.
• Prioritize, plan and schedule daily maintenance.
• Maintain facility grounds, including snow removal in winter.
• Special projects, including moving furniture for office reassignments, as they arise.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Drive company vehicles and snow plows as required.
• Other duties as assigned.

Minimum Requirements

• High school diploma or GED equivalent.
• Two to five (2-5) years facility maintenance experience 
• Certification in the maintenance field and/or willing to hold necessary certifications. 
• Preventive maintenance experience preferred.
• Ability to work independently with minimal supervision.
• Ability to prioritize workload to meet established timelines.
• Ability to climb and work from ladders.
• Mechanically inclined.
• Plumbing experience.
• Experience with HVAC systems.
• Experience with steam preferred.
• Good communication skills.
• Prior experience in a FDA manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Knowledge of OSHA regulations preferred.

Physical Requirements

• Frequently required to talk and hear
• Frequently required to stand and walk
• Occasionally required to climb
• Frequently required to kneel and stoop
• Occasionally required to crawl under equipment
• Frequently required to lift and/or move up to 25 pounds 
• Occasionally required to lift and/or move up to 50 pounds
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus. 
• Frequently required to work with cleaners, solvents and chemicals. MSDS sheets are provided. Required to wear respirator when working with certain chemicals 
• Occasionally required to work outside in inclement weather conditions

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disability Act to perform the essential functions of this job

Essential Responsibilities

• Interacts effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions. Ensuring that departmental timelines are met.
• Reviews technical documents for accuracy and acceptability for use in new NDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high quality submissions and expeditious approvals from FDA.
• Reviews and signs-off on change control documentation. Assess changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws.
• Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.
• Alongside Director, ensure regulatory program compliance for the company.
• Monitor and assist Quality Control department in the maintenance the Quality Management System (QMS) to ensure compliance with FDA and other regulatory requirements.
• Assist in the internal audit process, including the participation of GMP audits of the production facility on a regularly scheduled basis, and as necessary.
• Secondary contact for all external audits.
• Alongside the Director, assist in the external audit process, including preparation for ISO 9000 and customer audits.
• Review customer and regulatory requirements to ensure company compliance and to stay abreast of new or updated regulations.
• ISO 9000 and ISO 13485 management representative.
• Secondary FDA contact, including assisting with the annual FDA registration updates and keeping Drug and Device listings current.
• Ensure regulatory compliance on all materials and products.
• Consult in reviews of NCMs to ensure trends or systemic issues are identified and addressed.
• Assist in analyzing audit data and prepare reports for management review and continuous improvement initiatives.
• Perform tests of controls to provide an evaluation of the company’s internal control system, and prepare audit reports for these tests, documenting exceptions to established policies and procedures.
• Perform external quality audits on suppliers to ensure compliance with product specification.
• Assist in overseeing the maintenance of Quality and Audit files for facility.
• Assist in overseeing all Change Control activities to ensure compliance.
• Review all release documents to ensure compliance with Standard Operating Procedures (SOPs).
• Provide employee leadership through effective communications, coaching, training, and development. Provide leadership for problem resolution to facilitate fast improvements and improved working relationships.
• Ensure compliance with GMP, QSR/ISO, FDA, NSF, NRC, ATF, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance required.
• Adhere to company safety requirements.

Minimum Requirements

• Bachelor's degree in life science or related field (Or a combination of equivalent education and experience)

• 3+ years' experience working in a regulated industry

•  Problem solving skills

• Leadership skills and the ability to get results through others

• Good communication and interpersonal skills

• Proficient with Microsoft Office 

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk, and hear

• Frequently required to stand and walk

• Occasionally required to lift up to 20 pounds

• Vision ability including close vision, distance vision, color vision and the ability to adjust focus

• Ability to travel occasionally by air or car to attend business meetings and conduct audits

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

Minimum Requirements

• 2-4 years of maintenance technician experience.
• Associate’s degree or certificate in mechanical or industrial maintenance preferred.
• Knowledgeable in pneumatics, electrical, and mechanical systems diagnosis.
• Ability to use a variety of hand, and diagnostic tools.
• Frequency Drive, and PLC experience is a plus.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to follow written and verbal instruction.
• Ability to work independently with little direction.
• Ability to work as part of a team to complete projects.
• Ability to travel by car to support multiple-site facility.
• Proficient in Microsoft Office.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Design new machinery and ancillary equipment to support company goals.
• Design components, assemblies and create functional drawings using SolidWorks.
• Work with outside vendors and consultants.
• Draft specifications for mechanical, electrical and control components.
• Modify and integrate existing machinery, systems and process improvement to improve quality, increase throughput, decrease costs, and strengthen safety measures.
• Modify and generate PLC programs.
• Oversee Machine Shop operations, including supervision of the Machinist.
• Supervise the PLC Engineer and Junior Mechanical Engineer.
• Provide technical guidance within the Engineering and Operations departments.
• Provide technical and mechanical support for Production operations.
• Support new company initiatives in the areas of Manufacturing and Operations.
• As part of the Change Control process, develop and control product documentation (e.g. BOMs, routings, drawings, artwork, and specifications) using Sage 100 ERP and EtQ Reliance systems.
• Write test protocols, reports and documents related to new processes.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Adhere to company safety requirements.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Mechanical or Electrical Engineering.
• 5 or more years experience in Engineering, with automation background.
• Prior supervisory experience.
• Experience in a FDA manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• SolidWorks design experience.
• Knowledge of PLCs, continuous improvement principles, and sound safety practices.
• Experience with AB & Siemens PLC’s preferred.
• Electrical wiring experience preferred.
• Technical writing experience preferred.
• Good communication and interpersonal skills.
• Good analytical skills.
• Ability to work both independently with little direction, and as a member of a team.
• Ability to manage several projects at once to meet established timelines is essential.
• Proficient with Microsoft Office products including Word, Excel, Visio and Project.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to sit.
• Frequently required to walk and stand.
• Frequently required to bend at waist and knees.
• Occasionally required to crouch or kneel to get under machines.
• Regularly lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.
• Fine motor control to grasp and manipulate objects.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Establish and maintain an understanding of Unicep’s products and services and how they are applied in each market segment we serve.
• Serve as point of contact for assigned customers/programs.
• Provide project updates to supported APMs, PMs, and Management as necessary.
• Assist with the administration of the Quote process with a basic understanding of cost drivers, customer business needs and Unicep’s sales processes. Quote process entails interaction with quote team, suppliers, customers and sales executives.
• Input quote data into spreadsheet form for analysis and reporting.
• Process and enter Sales Orders.
• Assist APMs, PMs, and Management to administer customer contracts.
• Assist with New Product Introduction (NPI), product transfers, and end-of-life activities.  Generate and tracks cross-functional action item lists and ensure alignment with customer expectations.
• Assist with ongoing production for established programs by leading cross-functional teams, as required, to ensure that programs are conducted in accordance with the requirements of sales orders and program objectives, elevating unresolved issues to management. 
• Assist APMs and PMs with managing cash flow, budgets, forecasts, profit & loss, program timelines, resources, and key milestones.
• Write Work Orders and obtain required signatures.
• Identify and support development of organic growth opportunities with existing customer base.
• Generate, maintain and publish reports on cost, margins, and inventory levels.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Maintain regular attendance.
• Adhere to company safety requirements.
• Perform other duties as assigned.

Minimum Requirements

• Bachelor's degree in engineering or business preferred.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Basic knowledge of cost accounting and materials procurement preferred.
• Proven proficiency in managing timelines.
• Ability to read, analyze, and interpret common scientific and technical publications and reports.
• Ability to clearly and effectively communicate in both oral and written formats.
• Ability to effectively present information and respond to questions.
• Proficient with applied business and economic mathematics and analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and to deal with several abstract and concrete variables.
• Proficient in Microsoft Office products including Word, Excel & Project.
• Experience working in CRM databases with proficiency in Salesforce preferred.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Frequently required to walk.
• Frequently required to sit.
• Occasionally required to stand.
• Occasionally lift and/or move up to 25 pounds.
• Vision includes close vision, color vision and distance vision.
• Ability to travel by air or car to meet with customers.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Design and draft validation protocols for processes and equipment.
• Design and draft calibration protocols for equipment.
• Create draft validation protocols.
• Execute validation and calibration documents.
• Implement FDA/ISO documentation for equipment and/or processes including SOPs and preventive maintenance documents and forms.
• Work to ensure that calibrations are fully integrated to demonstrate that equipment consistently functions as intended to maintain regulatory compliance for the facility.
• Perform and document experiments to demonstrate that equipment and processes consistently function as intended to maintain regulatory compliance of the facility.
• Write draft reports based on data gathered during execution of validation documents.
• Support Engineering in compliance with FDA/ISO regulations.
• Assist with writing Standard Operating Procedures (SOPs), Preventive Maintenance procedures, and other documents for equipment and processes as needed.
• Consult with other departments on FDA/ISO regulatory compliance as requested.
• Perform initial reviews of equipment usage to determine if systems need to be re-validated or calibrated.
• Evaluate external calibration protocols and schedule external vendors for maintaining calibration needs of the organization.
• Evaluate external validation protocols.
• Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• All other responsibilities as required.

Minimum Requirements

• Bachelor’s degree in Science, Engineering, or a related field, or an equivalent combination of education and experience.
• Three years’ experience in Validation.
• One year’s experience in calibration.
• Knowledge of the Scientific Method.
• Knowledge of ISO and FDA requirements for GMP/GLP practices.
• Experience working in a FDA regulated manufacturing facility.
• Ability to work independently with minimal direction.
• Ability to prioritize workload to meet established deadlines.
• Familiar with Chemistry, Microbiology, and Engineering terminology.
• Ability to perform basic statistical calculations and analysis.
• Experience creating and maintaining documentation and reporting.
• Proficient in Microsoft Office.
• External qualification to a recognized certifying organization for calibrations is a plus, but is not required.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Required to sit for 3-4 hours at a time.
• Frequently required to walk and stand.
• Occasionally lift up to 25 pounds.
• Fine motor control to grasp small objects.
• Vision includes close vision, color vision and the ability to adjust focus.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Generate a pipeline through nurturing and qualifying leads, prospecting, cold calling, and face to face meetings of potential customers
• Understand applications for Unicep’s products and services in all target markets.
• Field inbound sales inquiries, qualify opportunities, and gather pertinent project information in preparation for quote.
• Identify decision makers amongst the targeted leads in order to begin sales process
• Follow up with customers continuously, responding to customer enquiries through calls, emails, and/or letters
• Work in CRM (Salesforce) to grow and maintain prospect/project database.
• Assist with inside sales support for direct mailings, samples, and other marketing/sales activities as needed
• Complete research projects as designated by management
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy
• Adhere to company safety requirements
• Other duties as assigned

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Business, Marketing, or a combination of equivalent experience and/or education
• Ability to learn about customer's market and core business processes
• Ability to learn, understand, and articulate the range of Unicep’s capabilities
• Superior communication skills with the ability to interact cross-functionally at all organizational levels
• Strong time management and prioritization skills with a demonstrated ability to execute multiple projects and excel in a results-oriented work environment
• Excellent written and oral communications skills
• Strong research and analytical skills
• Proficient with Microsoft Office products, including Word and Excel
• Familiarity with MAS 90 preferred
• Previous experience in a FDA-regulated manufacturing facility preferred
• Knowledge of GMP regulations preferred

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk and hear
• Frequently required to stand and walk
• Regularly lift and/or move up to 25 pounds
• Ability to travel
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Lead work centers and production lines as necessary.
• Maintains assigned machinery.
• Sustains awareness of production schedule and needs.
• Independently operate several types of production machinery after the successful completion of training and certification.
• Monitors production equipment to ensure a quality product.
• Perform machine set up and changeovers on various equipment and production lines.
• Follow established quality requirements for each product.
• Complies with all procedural requirements.
• Performs troubleshooting, adjustments, and preventative maintenance of production machinery.
• Reads and interprets equipment manuals and work orders to perform required maintenance and service.
• Work with Quality Control to ensure written documentation for production runs is complete, correct, and in compliance with company Good Documentation Practices and government regulations.
• Identifies and implements necessary documentation for compliance and works with Quality Assurance to ensure compliance.
• Follows guidelines to ensure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Adhere to all safety policies and procedures for operating equipment and handling raw materials and finished goods.
• Adhere to all company policies, procedures, and safety requirements.
• Maintain good housekeeping and a clean work area.
• Promote teamwork by working with others to achieve production efficiency, quality, and on-time delivery goals.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

• Associate’s degree or certificate in mechanical or industrial maintenance preferred. or equivalent.
• 2 – 4 years of manufacturing/production experience.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to read and interpret written policies and procedures.
• Ability to follow written and verbal instruction.
• Ability to work independently with little direction.
• Ability to work as part of a team to complete projects.
• Ability to complete paperwork fully and correctly.
• Good written and verbal communication skills.
• Ability to work with others to achieve goals.
• Ability to perform repetitive tasks.
• Proficient in Microsoft Office.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Occasionally required to sit.
• Frequently required to talk and hear.
• Frequently required to walk.
• Required to stand for 3 – 4 hours at a time.
• Regularly lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Fine motor control to grasp and manipulate objects.
• Frequently required to bend at waist and knees.
• Frequently required to reach.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.
• Frequently required to work with products that contain chemicals or may contain hazardous materials. MSDS sheets are required.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.