Engineer Senior, Process Development GMP Packaging JP

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 / Night shift

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 / Night shift

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

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

Supplement additional workload on team

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.

• 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

• 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

• 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

• Onsite…