Computer Systems Validations Manager

Ofni Systems is a rapidly growing FDA compliance and software validation company; we are currently seeking good candidates for the following position.

We are looking for an experienced Validation Manager to develop and grow our validation department. The candidate will work with top global pharmaceutical brands and manufacturers to ensure unparalleled validation services. The ideal candidate will be responsible for working directly with clients to scope projects and write proposals.  They will be responsible for growing and curating an industry leading computer validation team.


Education and Experience

Bachelor’s degree in computer science, engineering life science or related field plus 2 years experience with CSV validation lifecycle management, validation documentation development and 1 year project management, using a risk based methodology. 2 plus years Pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions. Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc. Excellent interpersonal, communication, organizational, and project management skills. Excellent presentation and writing skills. Supervisory/leadership experience preferred.

This is a key technical role responsible for validation testing documentation, development and execution of protocols, and strategic planning for compliant computerized operations in a GMP environment.  The position will focus on information systems and software applications in areas that include ERP, electronic record systems, laboratory and clinical information management systems and computerized instrumentation.


Contact Us About This Job

Principles only. Recruiters, please do not contact. Please, no phone calls about this job.