Equipment Maintenance Specialist
6 days ago
Berkshire Sterile Manufacturing LLC is seeking a skilled and detail-oriented Equipment Setup Technician to join our team. In this role, you will be responsible for setting up, operating, and maintaining our aseptic filling lines.
Key Responsibilities:
- Set up and operate aseptic filling lines, following Standard Operating Procedures (SOPs) and ensuring compliance with all applicable regulations.
- Install and maintain change parts and equipment, including filling machines, capping machines, and vial washers.
- Troubleshoot and repair equipment during aseptic filling operations.
- Provide real-time status updates of the operation of a line or individual piece of equipment.
- Train future team members in the set-up, routine operation, and troubleshooting of aseptic fill equipment.
- Study blueprints, sketches, drawings, specifications, and manuals to understand machine setup, operation, and troubleshooting.
- Coordinate with the Facilities Department to ensure timely preventative maintenance or request appropriate corrective maintenance on equipment.
- Assist the engineering and validation departments with installation, operation, and performance qualifications of manufacturing equipment.
- Write and revise Batch Records, SOPs, and notebook studies.
- Initiate and work on a variety of quality forms, including management of changes, deviations, event reports, and corrective and preventative actions.
- Learn and follow all good manufacturing practices and safety procedures.
- Other duties as assigned.
Supervisory Responsibilities:
- N/A
Requirements:
- Prior experience setting up and operating automated manufacturing equipment.
- Demonstrated mechanical knowledge.
Education:
- High school diploma or GED equivalent.
Knowledge, Skills & Abilities:
- Familiarity with formulation, filling, and primary packaging and aseptic processing.
- Experience with Microsoft Office and general computer proficiency.
- Attention to detail.
- Technical reading and writing.
- Able to follow rules and regulations.
- Mechanical aptitude.
- Resilient, able to quickly move forward despite challenges, thrives on challenges to improve skills and abilities.
- Honesty, integrity, respect, and courtesy with leadership and peers.
- Ability to build collaborative relationships.
- Strong adherence to verbal instructions.
- Can resolve routine and complex problems.
Physical Requirements:
- Ability to meet gowning requirements.
- Visual acuity.
- Fine and gross motor skills to manipulate tools and equipment.
- Ability to remain stationary for continuous prolonged periods of time.
- Able to occasionally lift 30-50 lbs.
- Able to wear PPE.
- Use of standard office equipment with or without reasonable accommodation.
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