Senior Equipment Qualification Engineer

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

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

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.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [e-mail]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.