Set-Up Maintenance Technician (10 pm-6:30 am)

American Regent • Hilliard, OH

3d • Onsite

About The Position

This position is a member of the Manufacturing Team, responsible for manufacturing safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role ensures aseptic and sanitary conditions, accurate record-keeping, and professional behavior. The team member will participate in all aspects of the Filling Process, including dispensing components, cleaning, assembling, and sterilizing equipment, and aseptic filling. This includes loading and operating filling and capping machinery, unloading finished product, and performing tear-down and line clearances. As a Senior Team Member, the Set-Up Technician will provide direction, training, and mentorship to Filling Operators. They will be qualified to perform setup of components, including fill volume adjustments, and troubleshoot and make minor repairs to filling process equipment. The role also involves contributing to proper batch documentation, overseeing the change parts program, and managing change parts within the spare parts management system.

Requirements

• High School Diploma or GED required.
• 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.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to perform basic mathematical calculations.
• Ability to work overtime as needed.
• Ability to maintain qualification to don APA gowning apparel, perform APA cleaning, operate washers, cappers and operate aseptic fill room independently.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, masks, and protective gloves.
• Employee must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to repeatedly lift and/or move up to 50 pounds.
• Employee must be able to stand for extended periods of time.
• Physically able to work using restricted access barrier (RABS) or isolation containment devices.
• Must maintain cleanroom gowning and respirator fit testing requirement.

Nice To Haves

• 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.
• Possesses Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.
• Ability to stand in one place for prolonged periods of time, monitoring equipment and processes.
• Ability to take feedback constructively and function in a team-oriented work environment.

Responsibilities

• Become qualified on setup, including making aseptic connections, performing fill volume adjustments, and performing minor adjustments/troubleshooting and corrective interventions.
• Assist all team members with equipment assembly and cleaning to support manufacturing activities.
• Ensure equipment and change part supply inventories are maintained and available for use in accordance with production schedules.
• Ensure only approved materials and equipment are utilized at all times.
• Ensure that personnel do not perform tasks for which they do not have accurate and approved training records.
• Execute daily, weekly, and monthly hands-on training plans, while maintaining a schedule of activities.
• Perform machine diagnostics and repairs as required.
• Perform breakdown as required post filling and reinstall change parts as necessary.
• Maintain qualification status to run filling equipment, load components, and perform routine interventions.
• Maintain cleanliness of manufacturing equipment and areas to support manufacturing activities.
• Sanitize/disinfect gowning pathways.
• When necessary, participate in filling line operating stations in support of filling, stoppering, and capping operations.
• Ensure that only approved documentation and procedures are utilized.
• 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.
• Perform duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures.
• Perform duties according to the company’s standard operating procedures (SOPs) and adhere to Good Manufacturing Practices (GMP).
• Ensure appropriate documentation of all work activities (cleaning, filling, etc.) are recorded accurately and in accordance with Good Documentation Practices (GDP).
• Proactively identify potential problems and present potential solutions to Production Supervisor or other leadership.
• Stock, gather, stage, and manage inventory of all manufacturing change parts, supplies, and equipment associated with fill lines.
• Oversee the cleanliness and storage of manufacturing change parts and equipment in and out of the required areas to support manufacturing activities.
• Sanitize/disinfect components, materials, and production supplies to support the manufacturing process.
• Become gown qualified, maintain training status, and wear gamma irradiated garments.
• Become qualified cleaner for the aseptic processing area.
• Collaborate with Maintenance/Engineering to perform advanced repairs/troubleshooting activities.
• Collaborate with Engineering on the implementation of any continuous improvement initiatives and/or design changes.
• Attend all training programs as required by Company SOPs, procedures, and policies.
• Perform any other tasks/duties as assigned by management.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED