Process Packaging Engineer

ACL Digital; New Albany (OH); On-site; USD 110,000 - 160,000; Full time

Job summary

ACL Digital seeks a Senior Process Packaging Engineer to lead and optimize automated packaging lines at the New Albany, OH site. You will install, validate, and improve packaging equipment, ensuring CQV readiness and rigorous GMP compliance.

This role requires hands-on troubleshooting, technical documentation, and collaboration across engineering, operations, and quality teams. The ideal candidate will have 4+ years GMP experience, KNEAT or Veeva familiarity, and the ability to work 12-hour

Qualifications

• 4+ years GMP experience with hands-on packaging equipment.
• Experience with CQV and GMP documentation systems (KNEAT or Veeva preferred).
• Bachelor's degree plus 4 years GMP experience; or higher degrees.
• Ability to work 12-hour rotating shifts and travel up to 10%.
• Strong technical writing and equipment verification experience.

Responsibilities

• Act as site expert in automated packaging equipment and device assembly.
• Lead CQV activities and author protocols, reports, risk assessments, deviations/CAPAs, and change controls.
• Support technical transfer of product portfolio to the Ohio site.
• Drive process improvements to packaging line performance and productivity.
• Coordinate cross-functional communication to meet milestones.

Skills

GMP experience

Hands-on packaging equipment

CQV

Technical documentation

Shift flexibility

Project management

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Doctorate

Associates degree

High school diploma

Tools

KNEAT

Veeva

GMP document systems

Job description

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
• 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