Engineer Senior, Process Development GMP Packaging - (JP14502)

New Albany, OH - USA

Hourly Salary: $ 42 - 46

Posted on: 18-09-2025

Vacancies: 1 Vacancy

Job Summary

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 sites 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 clients global sites.
Support operational excellence initiatives to increase throughput productivity and efficiency

Basic Qualifications:

Doctorate (no experience required)
OR Masters 2 years GMP experience
OR Bachelors 4 years GMP experience
OR Associates 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

Regards

3KC Talent Acquisition Team

Required Experience:

Director

Job Title: Engineer Senior Process Development GMP Packaging - (JP14502)Location: New Albany OH. 43054Employment Type: ContractBusiness Unit: Advanced Assembly & Final ProductDuration: 2 years (with likely extensions and/or conversion to permanent)Posting Date: 09/16/25Pay Rate: $42.00 - $46.00/hour...

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.