Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)

Job Title: Senior ProcessEngineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Process Development 
Duration: 18+ months with possible extensions and/or conversion to permanent
Posting Date: 3/6/2026
Pay Rate: $45 - $50/hour W2
Notes: Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / Weekend. 10% travel required - Must be able to travel internationally for work (Europe/Canada)

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - KNEAT or Veeva highly prefer.

Job Description:
The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio .
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 ~10% 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

Qualifications
- Basic (Education & Experience)
- 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
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

Why is the Position Open?
Planned project

Top Must Have Skills:

1. Equipment & Manufacturing Support
   Provide on-site support for GMP packaging and device assembly operations
   Troubleshoot equipment issues and improve reliability/performance
   Support automated and semi-automated assembly lines
   Monitor and trend equipment performance metrics
2. Process Improvement & Optimization
   Identify and implement process improvements to increase throughput and efficiency
   Analyze manufacturing data to drive continuous improvement initiatives
   Optimize packaging line capacity and performance
3. Documentation & Quality Systems
   Write, review, and manage GMP documents (protocols, reports, procedures)
   Own and manage deviations, CAPAs, and change controls
   Maintain and update the site master validation plan
   Use systems like KNEAT or Veeva for document control
4. Validation & Technical Projects (CQV)
   Lead or support commissioning, qualification, and validation (CQV) activities
   Support tech transfer of products into the Ohio site
   Ensure equipment and processes meet regulatory and quality requirements
5. Cross-Functional Collaboration
   Work with manufacturing, quality, engineering, and external vendors
   Coordinate with commercial and clinical teams
   Communicate progress on technical milestones and projects
6. Project & Vendor Management
   Support equipment-related projects and timelines
   Interface with equipment suppliers/vendors for troubleshooting and improvements
   Contribute to standardization efforts across sites
7. Flexible Operations Support
   Work swing shifts (day/night/weekend as needed)
   Provide support based on production demands
   Occasional travel (~10%)

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Red Flags:
1. Weak or No GMP Experience
2. Lack of Hands-On Equipment Experience
3. Poor Technical Writing / Documentation Skills
4. No Process Improvement Mindset
5. Limited Ownership or Leadership
6. Weak Communication & Cross-Functional Skills
7. Inflexibility with Schedule or On-Site Work
 
Interview process:
Virtual Interview, 2 rounds of 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