Process Engineer

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.

• - BS in engineering/sciences/related life science engineering with 2–5 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.

• - 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.

• - base pay $83,000–$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.