Job Description

Oversee the calibration, validation, and preventative maintenance program for CRL Malvern BPS to ensure production standards are continually met.

ESSENTIAL DUTIES AND RESPONSIBILITIES:• Supervise, manage and schedule work to calibrate and validate equipment to ensure adherence to calibration standards and guidelines.• Supervise, manage, and schedule all work related to the Preventative Maintenance program to ensure the preservation of critical equipment and work areas.• Provide, review and audit documentation in compliance with cGLPs and cGMPs.• Oversee all calibration and validation activities to specialized equipment, such as autoclaves, lyophilizers, vial washers etc. at Malvern locations and make recommendations to improve and enhance.• Responsible for the revision of Standard Operating Procedures for calibration and validation methods.• Assist in training of employees at other CRL domestic locations in calibration and validation methods.• Review and approve potential calibration/validation service contracts.• Generate, revise, and maintain qualification protocols for a variety of validated equipment.• Implement, maintain and monitor the DI water system.• Ensure that classified rooms are maintained and perform per ISO requirements.• Author deviation report and investigations, complete and mark thorough.• Implement effective CAPAs.• Participate in client audits.• Perform all other related duties as assigned.

QUALIFICATIONS:• Education: Bachelor's degree in mechanical, electrical or electronic engineering or related discipline.• Experience: Six to eight years related experience and/or training.• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.• Other: Experience in regulated industry (pharmaceutical or bio tech) strongly preferred.

Compensation Data

The pay rate for this role is $99,000 - $105,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.