3 Key Consulting, Inc.

Engineer Senior, Process Development GMP Packaging - (JP14502)

3 Key Consulting, Inc.  •  $42 - $46/hr  •  New Albany, OH (Onsite)  •  2 months ago
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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.


*** 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.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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