Senior Process Development Engineer — Validation & Lab Ops

Crystal Equation Corporation; New Albany (OH); On-site; USD 54,000 - 61,000; Full time

Benefits offered by this job

401K

Medical insurance

Paid time off

Parental leave

Job summary

Crystal Equation Corporation is seeking a Senior Onsite Engineer to lead validation of laboratory systems and equipment, ensuring compliant operation across Process Development. The role requires coordinating with Manufacturing, Engineering, Quality, and other functions to sustain validated state, drive efficiency, and support site readiness.

The incumbent will own day-to-day PD lab operations, support lab build-outs, transitions, and method transfers, and ensure data integrity and regulatory

Qualifications

• Master’s degree and/or 2 years in a GMP-regulated environment OR Bachelor’s degree and/or 5 years in a GMP-regulated environment.
• Experience with commissioning, qualification, and validation (CQV) of facilities and equipment.

Responsibilities

• Lead validations of laboratory systems, equipment, methods, and maintain validated state.
• Develop validation strategies aligned with regulatory expectations and standards.
• Oversee qualification, lifecycle management, and governance of PD laboratory assets.

Skills

GMP knowledge

Cross-functional collaboration

Communication skills

Education

Master’s or Bachelor’s degree in a GMP-related field

Tools

X-ray inspection systems

Keyence microscopes

Forensic analysis tools

Job description

Crystal Equation Corporation is seeking a Senior Onsite Engineer to lead validation of laboratory systems and equipment, ensuring compliant operation across Process Development. The role requires coordinating with Manufacturing, Engineering, Quality, and other functions to sustain validated state, drive efficiency, and support site readiness.

The incumbent will own day-to-day PD lab operations, support lab build-outs, transitions, and method transfers, and ensure data integrity and regulatory