Engineer Senior

Senior Process Development Engineer – Packaging Equipment

Swing shift - candidates need to have flexibility for different shifts. Dayshift / Night shift / Weekend 10% travel required - Must be able to travel internationally for work (Europe/Canada) 18 month contract to start Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - KNEAT or Veeva highly preferred The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio.

This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands and both on-site work and ~10% travel.

Key Functions & Outputs

• Project Management:
  Support technical transfer of product portfolio into the Ohio site. Drive continuous improvement in device assembly and packaging line capacity/performance. Communicate across the network to deliver technical milestones.
• Technical Leadership:
  Act as site expert in automated/semi-automated device assembly. Lead commissioning, qualification, and validation (CQV) of GMP equipment. Own and maintain the site master validation plan.
• Operational Excellence:
  Analyze, design, and implement manufacturing/business process improvements. Drive productivity, throughput, and efficiency gains.
• Quality and Document Management Systems:
  Able to author and manage various documents/protocols/reports. Deviation/CAPA/EV Owner. Change Control Owner.
• Relationships:
  Build networks with commercial and clinical operations. Provide support for equipment standardization, troubleshooting, and performance trending.

Qualifications

• Basic (Education & Experience):
  Doctorate (no experience required) OR Master's + 2 years GMP experience OR Bachelor's + 4 years GMP experience OR Associate's + 8 years GMP experience OR High School/GED + 10 years GMP experience
• Preferred:
  Combination product assembly equipment expertise Cross-functional project leadership experience Strong teamwork and communication skills Direct experience in devices, combination products, and packaging operations Supplier management experience (FDP equipment vendors) Adaptability in regulated, fast-paced environments Operational excellence / continuous improvement mindset