Engineer Senior, Process Development GMP Packaging - (JP14502)

Overview Job Title: Engineer Senior, Process Development GMP Packaging - (JP14502) Location: New Albany, OH. 43054 Employment Type: Contract Business Unit: Advanced Assembly & Final Product Duration: 2+ years (with likely extensions and/or conversion to permanent) Posting Date: 09/16/25 Pay Rate: $42.00 - $46.00/hour W2 Notes: Only qualified candidates need apply. Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift Job Description 3 Key Consulting is hiring an Engineer Senior, Process Development GMP Packaging - (JP14502) for a consulting engagement with our direct client, a leading global biopharmaceutical company. Schedule note: This is a swing shift position - 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, OH. 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 Why is the Position Open? Supplement additional workload on team Top Must Have Skills Expertise in Combination Product Assembly & Packaging Equipment Strong knowledge of automated and semi-automated device assembly, validation, and troubleshooting Experience in GMP-Regulated Environments Hands-on experience with technical transfer, regulatory compliance, and supporting commercial manufacturing operations Cross-Functional Project Leadership & Communication Skills Proven ability to lead technical projects, work across teams, and effectively communicate in a regulated, fast-moving industry Strong technical writing skills. Day to Day Responsibilities Serve as the technical lead for FDP assembly and packaging equipment (new and existing). Manage commissioning, qualification, and validation activities for GMP equipment, including ownership of the site’s master validation plan. Support technical transfer of new products into the site and ongoing optimization of packaging line performance. Provide manufacturing troubleshooting and equipment/process improvements. Build and leverage networks of technical experts across client’s global sites. Support operational excellence initiatives to increase throughput, productivity, and efficiency Basic Qualifications 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 Qualifications 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 Red Flags Onsite Requirement: This is an on-site role in New Albany, Ohio. Flexibility with Hours: While not explicitly stated as variable shifts, candidates should expect flexibility given the nature of GMP manufacturing, equipment commissioning, and troubleshooting demands. Travel Requirement: Must be able to travel 20% required for this role Candidate must be able to have great communication skills, project management, technical writing and be able adapt based on site priorities. Too much experience - 8+ years and a B.S. Interview process Virtual Teams Meeting 1:1 w/ Hiring Manager 1-2 Panel Interviews We invite qualified candidates to send your resume to View email address on click.appcast.io . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website . You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.