Our biopharmaceutical client has a permanent opening for a Computer Systems Validation Specialist
The scope of the role includes supporting all aspects of the Computer Systems Validation (CSV) Lifecycle.
The ideal candidate will execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
Track changes to the regulatory environment and implement processes/procedures, while enabling our client to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and data integrity.
- Complete the execution and documentation of the CSV Program. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
- Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from management, end users and clients, and provide status updates on a frequent basis.
- Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
- Work collaboratively to ensure the development of CSV best practices and promulgation to site CSV employees to support the timely delivery of validated computer systems for internal clients.
- Keep current on trends, new products and technologies, and regulatory requirements that may have an impact on CSV. Serve as the CSV SME during audits and for any standards.
- BS, MS or Ph.D. in an Information Technology discipline, and/or 1-3 years industry experience, or equivalent.
- Lab equipment validation knowledge and experience is required.
- Exposure to IT computer validation and alignment of IT validation with other validation requirements.
- Knowledge of biotech manufacturing obtained from a cGMP facility.
- Must be willing to travel up to 40% to other office locations, as needed.
- Demonstrated project management ability with good written and oral communication skills is required.
Experis is an Equal Opportunity Employer (EOE/AA)