Senior Process Development Engineer

Crystal Equation Corporation; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Crystal Equation Corporation seeks a Senior Process Development Engineer – Packaging Equipment to lead GMP packaging equipment tasks at the New Albany site. You will oversee CQV activities, instrument equipment, and drive process improvements across the packaging line.

The role requires hands-on experience with automated packaging, documentation leadership in CQV, and the ability to work across schedules to meet manufacturing demands.

Qualifications

• Minimum 4+ years GMP experience with a B.S., including hands-on experience with automated/semi-automated packaging or device assembly equipment, troubleshooting, characterization, and establishing process parameters/ranges.
• Experience leading CQV activities and authoring technical documents (protocols, reports, deviations, CAPAs, change controls).
• Familiarity with GMP documentation systems (KNEAT, Veeva) and on-site, flexible shift work.

Responsibilities

• Act as site expert in automated/semi-automated packaging equipment and device assembly.
• Lead equipment characterization to optimize operating conditions and determine process parameters, ranges and controls.
• Lead CQV activities for GMP equipment and own related protocols and reports.
• Support technical transfer of product portfolio to the Ohio site and drive packaging line improvements.
• Analyze and implement manufacturing process improvements to increase productivity and throughput.

Skills

GMP packaging equipment

CQV leadership

KNEAT or Veeva

shift flexibility

Education

B.S. degree

Tools

KNEAT

Veeva

Job description

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

Responsibilities

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

Required 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

Preferred Skills

• 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