Senior Specialist Engineering, Sterile​/Liquids; Onsite

Description – Sr. Specialist, Engineering Responsibilities

• Provide technical input on sterile processes from a facility/operational standpoint.
• Provide manufacturing project management oversight and GMP expertise to ensure timely availability of clinical supplies and development batches.
• Serve as the main interface with development scientists for manufacturing sterile liquid clinical and development batches.
• Manage deviations; lead process improvement projects.
• Implement new technologies and support process design.

• Education (required):
  Bachelor of Science in Chemical Engineering, Chemistry, Biology, or related scientific field.
• Experience/skills (required):
  • 3+ years in a technical or operations support role
  • Sterile process manufacturing and/or formulation development
  • Knowledge of manufacturing equipment and Good Manufacturing Practices (GMP)
  • Project management, analytical problem-solving, cross-functional leadership
  • Technical writing (batch documentation, investigations, protocols)
• Skills (as stated):
  Deviation management; batch production records; documentation preparation; equipment qualification; process development/engineering/design; process optimization; process hazard analysis (PHA); analytical/data analysis; problem identification.

• West Point, PA

Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, 401(k), paid holidays, vacation, and sick/compassionate days.