Lead Packaging Process Engineer – GMP CQV (On‑Site)

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

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.