Validation Engineer
Malvern, PA, US, 19355
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 Summary
Provide engineering oversight for validation of legacy and new equipment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• 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.
• Manage and maintain the site's DI water system and associated drops.
• 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.
• Assist in identifying what equipment in the lab needs to be replaced or removed.
• Assist with developing equipment requirements for laboratory purchases.
• May train others on proper use of equipment.
• Oversee daily operational activities of one non-exempt employee.
• Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans.
• May assist in development of departmental budget.
• As required, oversee maintenance of group training manual and training records.
• Support the policy of equal employment opportunity through affirmative action in personnel actions.
• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
• Author and revise qualification protocols and SOPs.
• Perform technical review of vendor generated calibration and certification reports.
• Perform all other related duties as assigned.
Job Qualifications
• 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.
• Certification/Licensure: None.
• Other: Computer files organizational skills. Computer application skills. Ability to read and follow all company SOPs and guidelines and demonstrated knowledge of cGMP regulations. Ability to work effectively as a member of a team, interact with internal and external clients during client site audits, conducting vendor audits, and interact with all levels of employees at the site for training and team events. Ability to manage multiple priorities, problem-solve and meet deadlines. Excellent verbal and written communication skills and ability to respond effectively to change. Champion new procedures which will improve or add value to new and existing assays. Knowledge of compendial monographs, 21 CFR Part 11 requirements, ICH guidelines and ISO standards as they apply to a regulatory environment.
Compensation Data
The pay range for this position is $78,500 - $80,000. 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 supported the development of 86% of the drugs approved by the FDA in 2021.
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 Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
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 [email protected]. 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.
Nearest Major Market: Philadelphia
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