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


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.

Job Description:
*** 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 resumes@3keyconsulting.com.  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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.