ACL Digital
Overview
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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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
#J-18808-Ljbffr