Senior Process Engineer
Charles River Laboratories International Inc (CRL)
Rockville, MD, US, 20850
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Provide oversight and implementation of engineering activities associated with GMP and non-GMP equipment to ensure compliance with applicable Current Good Manufacturing Practice (CGMP) regulations, corporate policies, and site Standard Operating Procedures (SOP's). Work closely with the operations and quality departments to develop calibration and preventative maintenance deliverables, ensuring fit for purpose and testing requirements that are defined and follow the Calibration Master Plan and applicable CGMP regulations.
Key Responsibilities and Duties:
• Prepare maintenance deliverables for equipment, including review of calibration and PM reports. • Coordinate and schedule system vendors with respect to the execution of calibration, preventative maintenance, and repairs to ensure compliance with site procedures, Calibration Master Plan, and regulatory requirements. • Assist system SMEs in the troubleshooting of various equipment. • Oversee system vendors while performing calibration, preventative maintenance, and repair service. • Work with Operations and Quality to assess risk and impact with respect to proposed changes within the facilities and equipment. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations. • Provide ongoing Calibration/PM and other appropriate System Lifecycle training/education of staff. • Organize an efficient method to ensure all requirements of assigned engineering deliverables are completed and that engineering efforts are executed in a timely manner. • Participate in the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during maintenance efforts regarding equipment, processes, facilities, SOPs, and other related issues to ensure compliance with applicable regulatory requirements/guidelines, procedures, and policies. • Author/participate in the development of engineering SOP’s. • Assist, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system engineering/maintenance. • Manage engineering/facilities contractors, as needed. • Manage facilities projects, as needed. • Provide technical review of calibration and preventative maintenance reports. • Perform all other related duties, as assigned.
• Bachelor’s degree or equivalent in a scientific, Engineering, IT discipline, or related field. • Preference given to candidates with a minimum of 5 years engineering related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of lab equipment/instrumentation, process, and facility maintenance in a regulated environment. • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. • Must have excellent oral and written communication skills. Strong documentation development and technical writing skills are critical to this position. • Must have in-depth knowledge of accepted industry practices and regulatory requirements that govern computer system validation in the pharmaceutical industry. 21 CFR Parts 210, 211, 820, 11, EU Annex 11, and applicable ICH and FDA guidance's. • Certifications/License: None • Leadership ability, project management, and facilitation skills required. Must be proficient with Microsoft Office software (Word, Excel, PowerPoint). Must have good interpersonal, organizational, and analytical skills.
The pay range for this position is $100,000-$110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 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.
Equal Employment OpportunityCharles 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.
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