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Engineer Senior, Process Development GMP Packaging - (JP14502)
Engineer Senior, Process Development GMP Packaging - (JP14502)3key Consulting, Inc. • New Albany, OH, US
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Engineer Senior, Process Development GMP Packaging - (JP14502)

Engineer Senior, Process Development GMP Packaging - (JP14502)

3key Consulting, Inc. • New Albany, OH, US
15 days ago
Job type
  • Permanent
Job description

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 / Nightshift

Job Description

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 / 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.

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    Senior Packaging Engineer • New Albany, OH, US