The Senior Computerized System Validation Engineer 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.
- Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specifications, Risk Assessments, Installation/Operational/Process Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
- Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
- Ensure all GxP systems maintain compliance by managing product release and update cycles.
- Review all GAMP 5 deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs)
- Works with stakeholders to maintain GxP computerized system and CSV SOPs.
- Responsible for all IT/OT change management and change control activities of the GxP platforms.
- Owns and maintains the CSV (GAMP 5) and Data Integrity programs.
- Must be able to create, review, and update SOPs, forms, templates, documentation, and files.
- Supports regulatory and client audits as CSV subject matter expert.
- Perform other duties as assigned.
- Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 3+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
- Working knowledge and expertise in computerized systems validation
- Thorough knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations
- Experience generating and executing (end to end validation) on some of the following systems:
- Regulatory Asset Manager
- Environmental monitoring
- Laboratory Information Management
- Software for the management of business processes (SAP)
- Quality Management System
- QC Systems (Empower, LabX
- Manufacturing Systems
- Excellent written and oral communication skills
- Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point)
- Ability to work with minimal supervision
How to Apply
If you feel that you are a great match for this position and want to make a difference in the exciting field of next-generation therapeutics, then reach out to us at [email protected] and be sure to include your resume and cover letter. We look forward to hearing from you!
Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture.
At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA. Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D. Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials. The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA. As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency. We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business. Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance. Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.
Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center. Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:
- Multicultural hub with great schools, restaurants, breweries, shopping, arts, and an affordable cost of living
- Gateway to the Green Mountains including world class hiking, camping, bicycling, and alpine and Nordic skiing