Senior Process Development Engineer – GMP Packaging Equipment JP

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

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

• New Albany, Ohio
• Biotech/Pharmaceutical

Job Title: Senior Process Engineer – Combination Products & Packaging GMP Manufacturing

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,…