Engineer Senior - No Experience

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