Responsibilities:
- Work with stakeholders to evaluate new/existing technologies to increase efficiency and facility throughput.
- Develop design documents (user requirement and software functional specifications) and support validation, commissioning, and qualification protocols.
- Assist with integrating equipment/technologies into the Distribute Control System (DCS) with the manufacturing suite.
- Evaluate single-use technologies; design single-use manifolds and assemblies.
- Work with vendors to develop data and validation packages.
- Facilitate procurement and implementation of approved new technologies.
- Develop business processes, guidelines, SOPs, and training for processing equipment/technologies.
- Lead equipment maintenance and life cycle plans.
- Partner with Site MSAT Manufacturing Technology & Science on global/site objectives.
- Support non-conformance/deviation investigations and provide process impact evaluations.
- Participate in technical problem/solution exchanges and internal/external audits/inspections.
Position Requirements:
- BS in engineering/sciences/related life science engineering with 2β5 years relevant experience in pharma/biotech/life sciences, or an MS degree.
- Working knowledge of cGMP and regulatory requirements for biologics/pharmaceuticals.
- Solid understanding of monoclonal antibody processing (manufacturing scale or process development).
- Experience with single-use disposable manufacturing systems.
- Ability to work independently and cross-functionally; quality/attention to detail; strong task/time management.
- Ability to organize, analyze/interpret, and communicate process data.
- Excellent oral and written communication.
Additional Preferred Qualifications:
- Continuous manufacturing experience; DeltaV automation.
- Experience in global teams/centers of excellence.
- CQV plan/protocol development and execution.
- Ability to lead projects within functional expertise.
Benefits/Pay (as stated): base pay $83,000β$86,250; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; basic life insurance; 401k match; flexible site-based work; paid time off/holidays; wellness and transportation.
Application Instructions:
- βTake the leap and apply today.β