Process Packaging Engineer

Job Title: Process Packaging Engineer Senior

Location: New Albany OH

Duration: 18 Months Contract

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

Top 3 Must Have Skill Sets:

Please prioritize candidates with a 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.

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 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

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