Nature and Scope
This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective, and professional behavior is always displayed. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Filling Process. The Filling Process includes dispensing components, cleaning, assembling, and sterilizing small and large pieces of equipment, and aseptic filling in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals. The Filling Process includes loading of glass vials, plastic bottles, caps, and seals into manufacturing machinery, operation of filling machine, operation of capping machine, unloading of finished product from the manufacturing machinery and the tear-down and line clearances of the manufacturing equipment.
The Set-Up Technician is considered a Senior Team Member and will be able to provide direction, training and mentorship to all Filling Operators as needed. The Set-Up Technician will be qualified to perform setup of components including fill volume adjustments. The Set-Up Technician will be able to troubleshoot most of the filling process and equipment and, where necessary, make adjustments and/or minor repairs during setup and during operations. The Set-Up Technician will be a contributing person for the proper use of batch documentation. The Set-up Technician will oversee the change parts program, working with Manufacturing, Maintenance and Engineering leadership to identify opportunities for improvement and participate in any required engineering studies outside of normal filling activities. The Set-Up Technician will manage the change parts within the spare parts management system and ensure all parts have specific asset I.D.s and new change parts are onboarded appropriately.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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Ability to become qualified on setup including making aseptic connections, performing fill volume adjustments along with minor adjustments / troubleshooting and corrective interventions.
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Assists all team members with equipment assembly and cleaning as required to support manufacturing activities.
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Ensures equipment and change part supply inventories are maintained and available for use in accordance with production schedules.
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Ensures only approved materials and equipment are utilized at all times.
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Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
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Executes daily, weekly and monthly hands-on training plans, while maintaining a schedule of activities.
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Ability to perform machine diagnostics and repairs as required.
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Performs breakdown as required post filling and reinstalls change parts as necessary.
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Maintains qualification status to run filling equipment, load components and perform routine interventions.
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Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
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Sanitization/disinfection of gowning pathways.
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When necessary, participates in filling line operating stations in support of filling, stoppering, and capping operation.
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Ensure that only approved documentation and procedures are utilized.
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Oversee production supply, materials and equipment gathering and staging activities required to support manufacturing. Oversee the electronic tracking of change parts in the available CMMS system.
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Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures.
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Perform duties according to the company’s standard operating procedures, (SOPs) and adheres to Good Manufacturing Practices (GMP).
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Ensure appropriate documentation of all work activities (cleaning, filling, etc.) are recorded accurately and in accordance with Good Documentation Practices (GDP).
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Proactively identifies potential problems and presents potential solutions to Production Supervisor or other leadership.
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Stocks, gathers, stages and manages inventory of all manufacturing change parts, supplies and equipment associated with fill lines.
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Oversees the cleanliness and storage of manufacturing change parts and equipment in and out of the required areas to support manufacturing activities.
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Sanitization/disinfection of components, materials and production supplies to support the manufacturing process.
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Required to become gown qualified, maintain training status and wear gamma irradiated garments consisting of a coverall, hood, mask, gloves, boots and goggles.
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Required to become qualified cleaner for the aseptic processing area.
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Collaborate with Maintenance/Engineering to perform advanced repairs/troubleshooting activities.
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Collaborate with Engineering on implementation of any continuous improvement initiatives and/or design changes.
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Attends all training programs as required by Company SOPs, procedures and policies.
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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High School Diploma or GED required.
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At least 2 years as a Filling Operator, having performed at a satisfactory level or 4+ years similar work experience in a related field is preferred. Maintenance experience is a plus.
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Possesses Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.
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Ability to stand in one place for prolonged periods of time, monitoring equipment and processes.
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Ability to take feedback constructively and function in a team-oriented work environment.
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Ability to become qualified to work within APA (and maintain access) to be able to perform aseptic fill room setup, breakdown and perform minor filling machine adjustments in all fill rooms within 6 months of position start date required.
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Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
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Ability to perform basic mathematical calculations.
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Ability to work overtime as needed.
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Ability to maintain qualification to don APA gowning apparel, perform APA cleaning, operate washers, cappers and operate aseptic fill room independently.
Physical Environment and Requirements
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Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, masks, and protective gloves. PPE are essential for the health and safety of employees.
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Employee must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
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Employee must be able to repeatedly lift and/or move up to 50 pounds.
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Employee must be able to stand for extended periods of time.
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Physically able to work using restricted access barrier (RABS) or isolation containment devices.
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Must maintain cleanroom gowning and respirator fit testing requirement.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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