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Crowe LLP

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Columbus, OH · On-site

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As of Jul 8, 2026, the average hourly pay for senior process associate in the United States is $18.43, according to ZipRecruiter salary data. Most workers in this role earn between $14.42 and $17.31 per hour, depending on experience, location, and employer.
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A map of the United States highlighting the number of Senior Process Associate job openings by state according to ZipRecruiter. The image is accompanied by a detailed chart listing the number of Senior Process Associate job openings in each state, with California having the most at 2 and Hawaii the least at 0.
Engineer Senior, Process Development GMP Packaging - (JP14502)

Engineer Senior, Process Development GMP Packaging - (JP14502)

3 Key Consulting

New Albany, OH • On-site

$42 - $46/hr

Other

Re-posted 24 days ago

Job description

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 sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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