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

American Regent, Inc.•Hilliard, OH

4d•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 materials, operating filling and capping machines, unloading finished product, and performing line clearances. The Set-Up Technician is a Senior Team Member who provides direction, training, and mentorship to Filling Operators. They are qualified to perform component setup, including fill volume adjustments, troubleshoot most filling process and equipment issues, and make minor adjustments or repairs. The Set-Up Technician contributes to proper batch documentation, oversees the change parts program, and works with leadership to identify improvements and participate in engineering studies. They manage change parts within the spare parts management system, ensuring proper asset identification and onboarding of new parts.

Requirements

High School Diploma or GED required.
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.
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.
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.

Nice To Haves

Maintenance experience is a plus.

Responsibilities

Ability to become qualified on setup including making aseptic connections, performing fill volume adjustments along with minor adjustments / troubleshooting and corrective interventions.
Assists all team members with equipment assembly and cleaning as required to support manufacturing activities.
Ensures equipment and change part supply inventories are maintained and available for use in accordance with production schedules.
Ensures only approved materials and equipment are utilized at all times.
Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
Executes daily, weekly and monthly hands-on training plans, while maintaining a schedule of activities.
Ability to perform machine diagnostics and repairs as required.
Performs breakdown as required post filling and reinstalls change parts as necessary.
Maintains qualification status to run filling equipment, load components and perform routine interventions.
Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
Sanitization/disinfection of gowning pathways.
When necessary, participates in filling line operating stations in support of filling, stoppering, and capping operation.
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.
Performs 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 adheres 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 identifies potential problems and presents potential solutions to Production Supervisor or other leadership.
Stocks, gathers, stages and manages inventory of all manufacturing change parts, supplies and equipment associated with fill lines.
Oversees the cleanliness and storage of manufacturing change parts and equipment in and out of the required areas to support manufacturing activities.
Sanitization/disinfection of components, materials and production supplies to support the manufacturing process.
Required to become gown qualified, maintain training status and wear gamma irradiated garments consisting of a coverall, hood, mask, gloves, boots and goggles.
Required to become qualified cleaner for the aseptic processing area.
Collaborate with Maintenance/Engineering to perform advanced repairs/troubleshooting activities.
Collaborate with Engineering on implementation of any continuous improvement initiatives and/or design changes.
Attends all training programs as required by Company SOPs, procedures and policies.
Perform any other tasks/duties as assigned by management.