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Validation Engineer

Req ID #:  45329
Location: 

Malvern, PA, US

For 70 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 Summary

This role will provide engineering oversight for validation of legacy and new equipment. 

 

We are seeking a Validation Engineer for our Biologics Testing Solutions site located in Malvern, PA

 

The following are responsibilities related to the Validation Engineer position:

  • Ensure optimum performance of the validation group's metrology function.
  • Oversee and support the testing phase of equipment monitoring systems validation efforts.
  • Oversee equipment validation efforts regarding the execution, development and training for the site.
  • Maintain, coordinate and schedule vendor certifications of clean rooms and associated equipment.
  • Represents the validation group with all site and equipment change control
  • Review vendor standard operating procedures, reports and protocols and maintain revision status as current.
  • Work closely with contractors, suppliers and vendors to troubleshoot or install equipment.

 

The following are minimum qualifications related to the Validation Engineer position:

  • Education: Bachelor's degree (B.A./B.S.) in engineering or related discipline.
  • Experience:  2-4 years related experience in a cGMP regulated environment. Experience involving active participation in metrology, equipment qualification and system validation efforts, preferably at the project management level. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Other: Computer files organizational skills and application skills. Follow company SOPs and guidelines and knowledge of cGMP regulations. Interact with internal and external clients during client site audits, conducting vendor audits, and interact with all employees for training and team events. Manage multiple priorities, problem-solve and meet deadlines. Excellent verbal and written communication skills . Champion new procedures which will improve or add value to new and existing processes. Knowledge of compendia monographs, 21 CFR Part 11 requirements, ICH guidelines and ISO standards as they apply to a regulatory environment.

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 14,000 employees within 80 facilities in 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. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

 

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 supported the development of ~85% of the drugs approved by the FDA in 2018.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

 

 

 


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