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Senior Process Development Engineer – GMP Packaging Equipment (JP15895)

3 Key Consulting

Job Location:

New Albany, OH - USA

Monthly Salary: USD 42 - 46

Posted: 29 September 2026 (6 days ago)

Application Deadline: 30 December 2026

Vacancies: 1 Vacancy

Job Summary

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: W2- Open Market Rate with benefits
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.