Senior Process Development Engineer – GMP Packaging Equipment - (JP15895)

Job Title: Senior Process Development Engineer – GMP Packaging Equipment - (JP15895)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process Development Group
Duration: 18 months with likely extensions and/or conversion to permanent
Posting Date: 09/23/2026
Pay Rate: $42 - $46/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Senior Process Engineer – Combination Products & Packaging GMP Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

- Seeking a technical engineer with hands-on experience supporting highly automated packaging equipment

- Strong experience with GMP, equipment verification, technical writing, and execution required

- KNEAT or Veeva experience highly preferred

- Ideal candidate: B.S. degree with 4+ years of GMP experience

- Must be flexible to work 12-hour rotating shifts, including days, swings, nights, and weekends. Role will initially start on day shift

- Potential 10% international travel to Europe/Canada

- Open market rate**

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
Technical Leadership:

- Act as site expert in automated/semi-automated packaging equipment and device assembly.

- Lead equipment characterization to optimize operating conditions and to establish appropriate process parameters, operating ranges, and controls.

- Lead commissioning, qualification, and validation (CQV) of GMP equipment.

- Own protocols, reports, risk assessments and other technical documentation

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.

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

Preferred

- Combination product assembly equipment expertise

- End to end integrated packaging equipment

- Hands of experience with euipment to establish parameters

- 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?
Supplement additional workload on team

Top Must Have Skills:

- Strong combination of hands-on automated packaging equipment experience, GMP, equipment verification, technical writing/execution, and KNEAT or Veeva experience, who are also fully comfortable with the required shift flexibility.

- Hands-on GMP Packaging Equipment Experience
- Minimum 4+ years GMP experience with a B.S., including direct hands-on experience with automated/semi-automated packaging or device assembly equipment, troubleshooting, characterization, and establishing process parameters/ranges.

- CQV & Technical Documentation Experience
- Demonstrated ability to lead/support commissioning, qualification, and validation (CQV) and independently author protocols, reports, risk assessments, deviations/CAPAs, and change controls. Experience with KNEAT, Veeva, or similar GMP document systems strongly preferred.

- Schedule & Travel Flexibility
-Must be able to provide on-site support across day, swing/night, and weekend shifts based on manufacturing needs.

Day to Day Responsibilities:

- Manufacturing Support: Partner directly with Manufacturing, Quality, Engineering, Validation, Automation, and Packaging Engineering to support commercial operations and planned/non-commercial equipment windows.

- Packaging Equipment Support: Provide hands-on technical support for automated/semi-automated packaging and device assembly equipment, including troubleshooting manufacturing issues and resolving equipment/process performance problems.

- Equipment Characterization & CQV: Execute and lead characterization, commissioning, qualification, and validation activities to establish appropriate equipment parameters, operating ranges, and controls.

- GMP Documentation: Author and execute protocols, technical reports, risk assessments, change controls, deviations, CAPAs, and effectiveness verifications using controlled document systems such as KNEAT/Veeva.

- Troubleshooting & Continuous Improvement: Analyze equipment downtime, recurring failures, throughput constraints, and process trends and implement improvements to reliability, capacity, and efficiency.

- NPI & Technical Transfer: Support new product introductions and technical transfers, ensuring packaging equipment and processes are ready for implementation.

- Vendor/Project Support: Work with equipment suppliers and internal project teams on equipment modifications, testing, FAT/SAT activities, and technical issues.

- Flexible Operational Coverage: Provide on-site support across day, swing/night, and weekend shifts as operational needs require.

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:

- Weak GMP/CQV & Documentation Ownership
- Experience is primarily non-GMP, or they only supported rather than authored/owned protocols, qualification activities, deviations, CAPAs, change controls, and technical reports.

- Little familiarity with controlled systems such as KNEAT/Veeva is another concern.

- Limited Schedule/Travel Flexibility
- Candidate is looking primarily for a standard day-shift or remote role and is hesitant about night/swing shifts, weekends, on-site manufacturing support.

Interview process:
1:1 or Panel Virtual Interviews with Hiring Manager and Supports

We invite qualified candidates to send your resume to [email protected] (mailto:[email protected]). If you decide that youre 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.