<p>Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / Weekend</p> <p>10% travel required - Must be able to travel internationally for work (Europe/Canada)</p> <p>18 month contract to start</p> <p>Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,</p> <p>technical writing & Document management system experience - KNEAT or Veeva highly preferred</p> <p>The Senior Process Development Engineer - Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio .</p> <p>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</p> <p>Key Functions & Outputs</p> <p>Project Management:</p> <ul> <li>Support technical transfer of product portfolio into the Ohio site. </li><li>Drive continuous improvement in device assembly and packaging line capacity/performance. </li><li>Communicate across the network to deliver technical milestones. </li></ul> <p>Technical Leadership:</p> <ul> <li>Act as site expert in automated/semi-automated device assembly. </li><li>Lead commissioning, qualification, and validation (CQV) of GMP equipment. </li><li>Own and maintain the site master validation plan. </li></ul> <p>Operational Excellence:</p> <ul> <li>Analyze, design, and implement manufacturing/business process improvements. </li><li>Drive productivity, throughput, and efficiency gains. </li></ul> <p>Quality and Document Management Systems:</p> <ul> <li>Able to author and manage various documents/protocols/reports </li><li>Deviation/CAPA/EV Owner </li><li>Change Control Owner </li></ul> <p>Relationships:</p> <ul> <li>Build networks with commercial and clinical operations. </li><li>Provide support for equipment standardization, troubleshooting, and performance trending </li></ul> <p>Qualifications</p> <ul> <li>Basic (Education & Experience) </li><li>Doctorate (no experience required) </li><li>OR Master's + 2 years GMP experience </li><li>OR Bachelor's + 4 years GMP experience </li><li>OR Associate's + 8 years GMP experience </li><li>OR High School/GED + 10 years GMP experience </li></ul> <p>Preferred</p> <p>Combination product assembly equipment expertise</p> <p>Cross-functional project leadership experience</p> <p>Strong teamwork and communication skills</p> <p>Direct experience in devices, combination products, and packaging operations</p> <p>Supplier management experience (FDP equipment vendors)</p> <p>Adaptability in regulated, fast-paced environments</p> <p>Operational excellence / continuous improvement mindset</p>