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.
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.
Job Summary
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.
Job Qualifications
- 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.
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