Senior Validation Engineer — GMP Calibration & Equipment

Charles River Laboratories; Malvern (Chester County); On-site; USD 99,000 - 105,000; Full time

Benefits offered by this job

Bonus incentives

401K

Paid time off

Stock purchase program

Health and wellness coverage

Employee wellbeing programs

Work life balance flexibility

Job summary

Charles River Biologics in Malvern, PA, seeks a seasoned professional to oversee calibration, validation, and preventive maintenance for CRL Malvern BPS. You will ensure production standards are met and drive compliance with cGLP/cGMP across validated equipment.

This role requires collaboration across sites and participation in client audits. The ideal candidate holds a Bachelor's degree in mechanical, electrical, or electronic engineering with 6–8 years in a regulated pharma/biotech environment

Qualifications

• Bachelor's degree in mechanical, electrical or electronic engineering or related discipline.
• Six to eight years related experience and/or training.
• Experience in regulated industry (pharmaceutical or biotech) strongly preferred.

Responsibilities

• Oversee calibration, validation, and preventative maintenance programs to ensure production standards are met.
• Supervise, manage and schedule calibration/validation work and the Preventative Maintenance program.
• Provide, review and audit documentation in compliance with cGLPs and cGMPs.
• Oversee calibration/validation activities on specialized equipment (autoclaves, lyophilizers, vial washers) at Malvern locations; propose improvements.
• Revise SOPs for calibration and validation methods.
• Assist in training CRL personnel in calibration/validation methods at other CRL locations.
• Review and approve potential calibration/validation service contracts.
• Generate, revise, and maintain qualification protocols for validated equipment.
• Implement and monitor DI water system; ensure ISO-compliant housekeeping of rooms.
• Prepare deviation reports and investigations; implement effective CAPAs.
• Participate in client audits.
• Perform related duties as assigned.

Skills

Calibration & validation

Preventative maintenance

Documentation

cGMP compliance

cGLP compliance

CAPAs

Audits

Education

Bachelor's degree in mechanical, electrical or electronic engineering

Tools

Autoclaves

Lyophilizers

Vial washers

Job description

Charles River Biologics in Malvern, PA, seeks a seasoned professional to oversee calibration, validation, and preventive maintenance for CRL Malvern BPS. You will ensure production standards are met and drive compliance with cGLP/cGMP across validated equipment.

This role requires collaboration across sites and participation in client audits. The ideal candidate holds a Bachelor's degree in mechanical, electrical, or electronic engineering with 6–8 years in a regulated pharma/biotech environment