Engineer Senior, Process Development GMP Packaging

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 . 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.

Regards,

3KC Talent Acquisition Team