Computer System Validation (CSV) Engineer III
Location: Alachua, Florida
( Relocation assistance may be provided for qualified candidates)
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies.
Placed in the forefront of our leading
– and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply.
With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client’s products from the laboratory to patients in need.
We work in close collaboration with each client’s team to deliver successful programs.
Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases.
The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients.
This exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market.
Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we’ll enable breakthroughs in science that improve patients’ lives and bring hope for a healthier world!
How will you make an impact?
The CSV Validation Engineer III 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, Computer Systems Validation (CSV) and Lifecycle procedures with 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?
Serve as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.
Perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11, Annex 11 and Data Integrity.
Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Thermo Fisher Scientific policies and procedures.
Validation projects may include manufacturing systems, lab systems, facilities systems and steady state activities around these applications.
Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.
Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.
Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.
Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
Coordinate and provide training and/or opportunities for career development of others.
Perform other duties as assigned.
How will you get here?
Education
Technical Degree or B.S.
Degree in Engineering.
Degree in Computer Sciences, Computer Engineering is highly preferred.
Experience
Must have a minimum of four (4) years’ experience in a pharmaceutical GMP environment.
Must have a minimum of three (3) years direct CSV validation experience.
Candidates with other technical bachelor’s degrees will be considered if they have three (3) or more years of direct validation experience.
Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
Knowledge in computerized system lifecycle activities, CSV and IT controls in a regulated environment.
Solid Knowledge of validation of cGMP automation/computerized systems is preferred within an EMA/FDA regulated environment.
Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
Experience with system validation across GxP landscape, specifically GMP applications.
Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.
Experience with the qualification of single use technology is desired.
Knowledge, Skills, Abilities
Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g.
FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or Pharmaceutical industry
Excellent communication and listening skills
Ability to build and maintain strong collaborative relationships across multiple departments
Microsoft Office and database management skills
Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
Ability to lift up to 50 pounds.
Work Hours: Monday to Friday, 8:00am to 5:00PM 40hrs week.
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.