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

3 Key Consulting•New Albany, OH

15d•Onsite

About The Position

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. 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.

Requirements

B.S. degree with 4+ years of GMP experience
Must be flexible to work 12-hour rotating shifts, including days, swings, nights, and weekends.
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.
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
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.

Nice To Haves

KNEAT or Veeva experience highly preferred
Preferred Combination product assembly equipment expertise
End to end integrated packaging equipment
Hands of experience with equipment 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

Responsibilities

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.
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.
Analyze, design, and implement manufacturing/business process improvements.
Drive productivity, throughput, and efficiency gains.
Able to author and manage various documents/protocols/reports.
Deviation/CAPA/EV Owner.
Change Control Owner.
Build networks with commercial and clinical operations.
Provide support for equipment standardization, troubleshooting, and performance trending.
Partner directly with Manufacturing, Quality, Engineering, Validation, Automation, and Packaging Engineering to support commercial operations and planned/non-commercial equipment windows.
Provide hands-on technical support for automated/semi-automated packaging and device assembly equipment, including troubleshooting manufacturing issues and resolving equipment/process performance problems.
Execute and lead characterization, commissioning, qualification, and validation activities to establish appropriate equipment parameters, operating ranges, and controls.
Author and execute protocols, technical reports, risk assessments, change controls, deviations, CAPAs, and effectiveness verifications using controlled document systems such as KNEAT/Veeva.
Analyze equipment downtime, recurring failures, throughput constraints, and process trends and implement improvements to reliability, capacity, and efficiency.
Support new product introductions and technical transfers, ensuring packaging equipment and processes are ready for implementation.
Work with equipment suppliers and internal project teams on equipment modifications, testing, FAT/SAT activities, and technical issues.
Provide on-site support across day, swing/night, and weekend shifts as operational needs require.