Thermo Fisher Scientific Computer Systems Validation Lead in Cambridge, Massachusetts
Thermo Fisher Scientific's Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
How will you make an Impact:
The Computer Systems Validation Lead will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV) and Lifecycle procedures, and Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. The incumbent will provide the necessary oversight of system related issues, employ risk-based methodology, and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives and solving compliance issues.
What will you do:
Provide oversight of all GxP Computerized Systems, including IT and Automation systems, QC software, and IT infrastructure.
Develop and approve system lifecycle documentation to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported to support CSV activities for assigned systems, including associated change requests.
Maintain GxP computerized system inventory list.
Represent IT Quality on all assigned projects in support of CSV activities.
Consult on conformance of validation strategies and lifecycle deliverables to current regulatory requirements and company procedures.
Provide timely and proactive support and guidance to IT and automation personnel in their System Development Lifecycle (SDLC) efforts to facilitate project timelines.
Provide IT quality oversight of system-related issues.
Employ risk-based methodology, where feasible and achievable.
Escalate any potential compliance issues in a timely manner.
Lead or support the development of procedures, work instructions, validation templates and training materials to ensure that the control of GxP computerized systems is integrated into Quality Management System.
Support internal and client audits and regulatory inspections.
Provide support in other quality system related activities including quality exceptions and change control.
How will you get here:
BA/BS required in Life Sciences or IT related discipline with 5 years of appropriate work experience.
3+ or more years working in a Quality role desired. Life Sciences biotech / pharmaceutical experience required.
Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
Knowledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment.
Experience with system validation across GxP landscape, specifically GMP applications.
Strong communication skills, both verbal and written.
Ability to work both independently and with teams at various levels in the organization.
Ability to work in a very dynamic environment with a clear sense of urgency.
Excellent organizational skills and attention to detail and accuracy.
Experience supporting health authority inspections a plus.
Strong computer skills including Microsoft Word, Excel, and Access.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner, and safer.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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