Spclst, Engineering
About The Position
Seeking candidates for a Specialist position within our company's research laboratories Biologics Pilot Plant (BPP) Equipment Engineering Team. This person will perform various activities regarding equipment maintenance and engineering supporting pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk vaccine clinical supplies. The candidate will participate in a wide range of activities including, but not limited to: Providing maintenance staff with support for all scheduled work associated with designated equipment Scheduling equipment calibrations and preventative maintenance Conducting equipment Lock Out / Tag Out Managing qualified equipment inventories Supporting equipment validation activities Authoring, reviewing, and approving change management documentation Providing engineering guidance for equipment upsets and events Ensuring GMP status of equipment and facilities Conducting Equipment Qualification Periodic Review for designated equipment Creating equipment and facility work notifications for corrective maintenance Maintaining/managing equipment parts lists for designated equipment, ordering special parts when needed. Managing small parts/accessories for equipment Leading small capital projects Evaluating new technologies and equipment for potential use in the area Supporting environmental and safety initiatives A good understanding of the regulatory guidelines governing GMP operations is important. Candidate is expected to work in a team atmosphere in close collaboration with plant personnel, EM&U, Quality, environmental, and safety groups. Some overtime (including weekends) will be required as well as occasionally supporting off-hour manufacturing.
Requirements
- Previous experience supporting equipment and/or GMP manufacturing facilities, or laboratory areas
- Strong teamwork and collaboration
- Extensive knowledge of cGMP, Quality Systems, and equipment safety
- Highly self-motivated with the ability to work in a fast-paced and dynamic setting
- Bachelor’s degree in Engineering with minimum 3 years of relevant experience OR Master’s degree in Engineering
- Candidates with a degree in a non-technical discipline plus relevant experience in pharmaceutical/biologics equipment management will be considered in lieu of a formal engineering degree
Nice To Haves
- Excellent organizational, problem-solving, and project management skills
- Strong technical background on pharmaceutical production equipment
- Experience working on teams in a matrixed organization
Responsibilities
- Providing maintenance staff with support for all scheduled work associated with designated equipment
- Scheduling equipment calibrations and preventative maintenance
- Conducting equipment Lock Out / Tag Out
- Managing qualified equipment inventories
- Supporting equipment validation activities
- Authoring, reviewing, and approving change management documentation
- Providing engineering guidance for equipment upsets and events
- Ensuring GMP status of equipment and facilities
- Conducting Equipment Qualification Periodic Review for designated equipment
- Creating equipment and facility work notifications for corrective maintenance
- Maintaining/managing equipment parts lists for designated equipment, ordering special parts when needed. Managing small parts/accessories for equipment
- Leading small capital projects
- Evaluating new technologies and equipment for potential use in the area
- Supporting environmental and safety initiatives
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
