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We are seeking a skilled Equipment Engineer to join our client’s operations team. This role is critical for implementing process improvements, maintaining equipment performance, and supporting continuous improvement initiatives in a highly regulated environment.
The ideal candidate will have experience in pharmaceuticals and/or biologics, GMP manufacturing, and knowledge of aseptic filling, sterile processing, and labeling.
Essential Functions
- Resolve issues that arise in day to day running of operation and providing timely responses and solutions
- Function closely with operations personnel to understand their interaction with equipment and resolve issues they face
- Implement solutions in collaboration with cross-functional technical teams and site leadership team
- Support filling equipment, formulation process, visual inspection equipment, and/or labeling process.
- Evaluate and improve efficiency of manufacturing instruments, equipment, and tools
- Evaluate and implement new changes
- Support operations through standard operating procedure revision
- Participate and/or support process FMEAs to understand process and product risks
- Provide technical support to manufacturing activities
- Work flexible hours to ensure production facility coverage
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Minimum Education and Experience:
- Bachelor’s degree in the engineering field or bachelor’s degree in life sciences with 3+ years of relevant work experience
- Or High School Diploma/GED 8+ years of relevant work experience
Additional Preferences:
- Lean Six Sigma Certification
- Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), visual inspection, and labeling
