Senior Maintenance Technician-GMP
3 weeks ago
In this role, you will be expected to work a 12-hour shift (6:30PM-7:30AM), Thursday through Saturday, and alternating Wednesdays. The schedule during the initial on-boarding/training phase (2-6 weeks) will be Monday through Friday, approximately 8am to 5pm
The Sr. Maintenance Technician role will be responsible for performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas.
Responsibilities include:
Developing, writing, and completing various quality systems and safety documentation such as:
· Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc.
· Responsible for various aspects of building, utility and production systems/equipment
· All work must be completed in a safe (in accordance to HRA, JHA, etc), timely manner according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMP), SOP, Code of Federal Regulations (CFR) and client procedures. This role interacts with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services.
- Provide training for staff, clients and projects, audit support, reviews and technically approves maintenance reports, forms, plans and records, develops, revises, and reviews equipment, maintenance or other related procedures, Interpret and revise loops sheets, electrical schematics, P&ID's, I/O wiring and panel drawings
Routinely perform moderately-complex to complex processes according to Standard Operating Procedure (SOP). Specific responsibilities include inspection and packaging of product-filled vials per procedures and batch records.
Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process.
Reconcile components and products, and calculate product exposure to room temperatures;
Skills: ; filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system ; basic GMP knowledge
Good Communication
Team Leadership
Troubleshooting System experience
Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process.
Reconcile components and products, and calculate product exposure to room temperatures;
Skills: ; filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system ; basic GMP knowledge
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