Senior Process Engineer – Packaging

Infotree Global Solutions; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Infotree Global Solutions is seeking a Senior Process Development Engineer – Packaging Equipment to provide technical leadership for automated packaging lines in our Ohio facility. You will drive CQV activities, establish process parameters, and author GMP documentation to ensure compliant, efficient operations.

The role requires hands-on experience with packaging equipment, cross-functional collaboration, and the ability to work rotating shifts to meet manufacturing needs.

Qualifications

• Minimum 4+ years GMP experience with a B.S., including direct hands-on experience with automated/semi-automated packaging or device assembly equipment.
• Experience leading commissioning, qualification, and validation (CQV) and authoring protocols, reports, deviations/CAPAs, and change controls.

Responsibilities

• Provide on-site technical leadership for packaging equipment and device assembly.
• Lead CQV activities and establish equipment parameters, operating ranges, and controls.
• Author GMP documentation using systems like KNEAT or Veeva.
• Support NPI/technical transfer and continuous improvement across packaging operations.

Skills

Hands-on GMP packaging equipment

Technical writing

CQV experience

Shift flexibility

Education

BS degree

Tools

KNEAT

Veeva

Job description

The Senior Process Development Engineer – Packaging Equipment 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.

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
• Adaptability in regulated, fast-paced environments
• Operational excellence / continuous improvement mindset

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.

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.

Notes:

• 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 and then transition to swings
• Potential 10% international travel to Europe/Canada