When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
How will you make an impact?
The QA Compliance Engineer will act as a direct liaison between departments and the site’s quality unit to ensure adherence to expectation of the GMPs are being met and facilitating projects through the site’s Quality Systems. This Quality Assurance member is essential to the compliant state of the facility and equipment for the GMP production of Cell Gene Therapies for clinical and commercial products. This role will interface closely with other cross-functional groups such as, Facilities, Engineering, CQV, QC, Operations and Quality.
What will you do?
- QA Compliance Engineer will be responsible for supporting GMP activities related to Facilities, Utilities, Engineering and Manufacturing Equipment.
- Review and approval of documentation and Quality Systems related to engineering, validation/qualification, facilities and utilities support.
- Provide quality oversight of facility and equipment commissioning and qualification activities
- Review and approve validation protocols pre and post execution. Work with impacted departments to resolve discrepancies and ensure equipment remains in a validated state.
- Provide quality oversight of the preventative maintenance and calibration programs. Ensure maintenance and calibration failures are properly investigated for impact to product quality, validation, regulatory requirements, etc.
- Provide quality oversight to facilities programs including but not limited to pest control, alarm management, work orders, facility shutdown and disruptions. Work with departments to develop robust programs that meet industry standards and regulatory expectations.
- Review and approve change controls with a focus on those pertaining to equipment, facilities, utilities and process changes ensuring validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
- Perform reviews of validation lifecycle documents including, but not limited to, Functional, Detailed Design, Configuration and User Requirement Specifications.
- Provide QA support and approval of risk assessments including but not limited to Risk Estimation Matrix (REM), Failure Mode and Effects Analysis (FMEA)
- Support external audits performed by regulatory/inspection agencies or clients and audit/inspection readiness activities.
- Lead and / or support thorough investigations of facilities, engineering and validation related quality issues (CAPA’s, Deviations, Discrepancies, Audit Observations, etc.) ensuring effective corrective and / or preventive actions occur.
- Participate in cross-functional teams to support continuous improvement activities such as the implementation of a Manufacturing Execution System (MES) and expansion of manufacturing capabilities
How will you get here?
- BS/MS in Engineering or related science discipline and 5+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations.
- Experience in setting up GMP operations and systems in a new facility is beneficial, in addition to experience in cell or gene therapy.
- Experienced in QA oversight of validation activities including computerized systems
- Experience with preventative maintenance programs, calibration programs and Computerized Maintenance Management Systems (CMMS)
Knowledge, Skills, Abilities
- Proficient in writing and approving Quality Systems including but not limited to deviations, change controls, CAPA
- Skilled in use of Microsoft Outlook, Powerpoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
- Knowledge of plant utility and equipment systems from the QA support perspective
- This position requires the ability to work in a fast-paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
- Able to review and provide details to ensure accurate written records, manage time effectively and be organized
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.