Senior Process Development Engineer GMP Packaging Equipment - (

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 . 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.