Engineer Senior

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ACL Digital
New Albany, OH, United States
  • Production
  • FlexTime
  • FullTime
  • Shift
  • Applications have closed

Swing shift – candidates need to have flexibility for different shifts. Dayshift / Nightshift

Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,
technical writing & Document management system experience – Kneat or Viva 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 ~20% 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

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