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

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

• 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

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.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for setting department objectives and securing resources to meet company strategic goals.
• Supervise Manufacturing Engineers, and facilities and maintenance empolyees.

• Provides leadership for employees through effective communication, coaching, training, and development.
• Provides leadership for problem resolution to facilitate fast improvements and improved working relationships.
• Develops and implements a culture of continuous improvement through the utilization of self-directed work teams.

• Leads design engineering related to new product development and product & systems enhancements.
• Develops and oversees the facility maintenance and preventive maintenance program, ensuring timelines are met.
• Develops and oversees machine and process validation programs, ensuring validation timelines are met.
• Work with production to be aware of production schedule and needs, ensuring manufacturing engineering is working as a team with production to achieve goals.
• Prepare and manage capital projects including identifying scope, cost, milestones, etc.
• Establishes, prepares, implements, revises, and maintains policies and procedures related to engineering and facilities.
• Regular attendance is an essential function of this position.
• Ability to travel by car or air to various facilities or customer sites.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in engineering.
• PE designation preferred.
• 8-10 years progressive engineering experience.
• Prior supervisory experience.
• Demonstrated ability to lead people and get results through others.
• Knowledge of cGMP requirements for the pharmaceutical industry preferred.
• Good communication and interpersonal skills.
• Demonstrated project management experience.
• Proficient with Microsoft Office (Word, Excel, Project).
• Ability to manage multiple projects and prioritize to meet established timelines.

PHYSICAL REQUIREMENTS:

• Frequently required to talk or hear.
• Frequently required to sit, stand, and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to 20 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.

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

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

• 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

• Develops, publishes, and maintains the Master Production Schedule, balancing inventory, resources and capacity. Negotiates corrective actions to product schedules when dictated by changes in business.
• Acts as liaison between Production, Engineering, Purchasing, and Sales to control the Master Schedule. Assists other production support groups in achieving corporate goals.
• Participates in new/sustaining product teams, representing materials, scheduling, and revenue concerns.
• Participates in Change Control Board (CCB) activity to ensure engineering changes are consistent with the production plans and inventories. Coordinates Engineering Change Notice effectiveness with Purchasing, Planning, and Production.
• Develops and documents internal and interface procedures to ensure consistent Master Scheduling policy, and for assembly scheduling in facilities worldwide. Works to optimize schedule to achieve corporate goals of revenue, profitability and cost savings. Reports changes to projected monthly or quarterly goals.
• Assists with system implementation issues relative to the Master Scheduling process.
• Assists Program Management in scheduling sales orders and supporting customer requirements.
• Develops and maintains planning bills of material and planning databases.
• Monitors performance to Master Schedule.
• Analyzes and updates system planning data such as lead times, safety stock, distribution resource planning, time fence, etc.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate the Customer Complaint program against defined parameters. Ensure that Complaints are documented; work with other departments to coordinate investigations. Track Complaint status to ensure the Customer receives a response within 30 days. Log, track, and ensure that the Customer Complaint procedure is maintained in a compliant state.
• Coordinate the Corrective and Preventive Action (CAPA) program against defined parameters. Ensure that CAPAs are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the CAPA procedure is maintained in a compliant state.
• Coordinate Nonconformance system. Ensure that nonconformances are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Nonconformance procedure is maintained in a compliant state.
• Coordinate the Deviation system. Ensure that deviations are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Deviation procedure is maintained in a compliant state.
• Coordinate the Internal Audit Program. Ensure procedures are maintained, training is provided for internal auditors, annual audits scheduled, and responsibilities assigned to audit team. Coordinate the generation of CAPAs for audit findings and ensure follow up from responsible parties.
• Gather and present audit data and prepare reports for management review and continuous improvement initiatives.
• Participate in regulatory and customer audits as needed.
• Ensure compliance GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school graduate or equivalent.
• 1 – 3 years in a manufacturing environment with at least one of those years in a quality role preferred.
• Ability to follow written and oral instruction.
• Ability to work both independently and as a member of a team.
• Excellent attention to detail.
• Proficient with Microsoft Office products including Word and Excel
• Ability to prioritize tasks to meet established timelines.
• Excellent interpersonal skills.
• Good organizational skills.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations.

PHYSICAL REQUIREMENTS:

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

Essential Responsibilities

• Perform all aspects of purchasing company products and services, including raw materials, packaging supplies, and MRO (Maintenance, Repair and Operations), in accordance with company policy.
• Source the most competitive pricing and best quality products.
• Perform negotiation of cash discounts, volume purchasing discounts, and pricing of all materials.
• Review material requirements as defined by the company’s ERP system to ensure proper inventory levels are maintained.
• Process purchase orders, ensuring documents are completed thoroughly and accurately.
• Maintain purchasing and inventory records, including pricing history and vendor relations.
• Confirm and update vendor list and participate in quarterly vendor performance review.  Make recommendations for change to vendor list as needed.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

• High school diploma or equivalent.
• Prior experience in a Purchasing Department for a manufacturing company preferred.
• Experience in a FDA-regulated facility preferred.
• Knowledge of cGMP regulations preferred.
• Good negotiating and communication skills.
• Proficient with Microsoft Office products, including Word and Excel.
• Good organizational skills.
• Good attention to detail.
• Ability to work both independently and as a member of a team.
• Ability to prioritize tasks to meet established deadlines.
• Ability to communicate effectively and professionally with people at all levels within the organization and external contacts.
• Solid decision making skills.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to sit and walk.
• Occasionally required to stand.
• Occasionally lift and/or move up to 25 pounds.
• Vision includes close vision, color vision and distance vision.

Essential Responsibilities

• Responsible for payroll including processing bi-weekly paychecks and direct deposits, maintenance of employee records, computation of withholdings, and submission of withholdings to the appropriate agency to meet established timelines.
• Process quarterly and year-end payroll tax filings and annual W-2 and 1099 forms.
• Responsible for accounts payable including verifying invoices for payment and ensuring expenditures are coded to the correct department.
• Invoice, monitor and process accounts receivable collections from customers. Reconcile customer accounts and follow up on past due invoices.
• Assist with maintaining general ledger, including preparing journal entries, account reconciliations, and month-end close processes.
• Provide information requested by external auditors to support documentation of annual reviews.
• Maintain records of financial documents with supporting materials.
• Reconcile inventory detail to the general ledger and resolve any issues that may arise.
• Recommend, design and implement department processes and protocols.
• Perform financial analysis as requested.
• Assist with monthly forecasting processes.
• Assist with special projects as requested.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Accounting or a combination of equivalent experience and education.
• 3-5 years accounting experience, including processing of payroll and accounts payable.
• Excellent communication skills, both verbal and written.
• Proficient with Microsoft Office products, including Word and Excel.
• Ability to work both independently and as a member of a team.
• Ability to prioritize tasks to meet established timelines.
• Good attention to detail.
• Good interpersonal skills.
• Good organizational skills.
• Good time management skills.
• Familiarity with Sage 100 ERP system preferred.
• Previous experience in a FDA-regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Frequently required to sit and walk.
• Occasionally required to stand.
• Frequently required to talk and hear.
• Occasionally lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
• Good manual dexterity to handle small 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.