Responsible for daily GMP operations in the Vertex Drug Product Facility, including the set-up, assembly, operation, disassembly, and cleaning of process equipment. Responsible for daily operation and staff allocations for second shift personnel. Oversees daily work of second shift personnel.
Key Responsibilities include but are not limited to:
- Excellent understanding of and strict adherence to cGMP requirements including:
- Compliance with all on-going training requirements.
- Following SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility.
- Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility.
- Execute and witness batch record instructions during cGMP operations.
- Maintain facility in an audit ready state.
- Interface with relevant cross functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product.
- Supervision of manufacturing personnel
- High School or Vocational School Diploma with 8+ years relevant work experience
- Ability to follow verbal and written instructions
- Visual Acuity
- Ability to distinguish between the colors red, yellow, blue and green
- Ability to lift up to 50lbs
- High mechanical aptitude and the ability to assemble precise equipment with basic and complex tools
- Strong organizational skills
- Strong communication skills, as well as excellent documentation skills
- A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment
- Basic computer skills and demonstrated ability to learn new systems and understand new technologies
- Supervisory experience
**Core hours are Monday Friday, second shift When not in production, ability to work first shift strongly preferred*** The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- Experience with manufacturing systems utilizing advanced computerized control systems and HMIs
- Experience with continuous manufacturing
- Experience with solid oral dosage manufacturing processes
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