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.

Responsibilities

Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
Coach the implementation teams in the proper execution of validation documents
Evaluate proposed changes to validated computer systems and recommend level of validation activities required
Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses
Identify and qualify all computer systems which impact cGMP operations using a risk based methodology
Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
Act as a CSV Lead for all validation projects
Execute or oversee the execution of validation plans and validation documents
Perform project management activities for CSV process within the scope of an overall system project
Work with overall project manager to include validation activities in implementation timelines
Manage internal CSV resources to facilitate completion of qualification activities
Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
Conduct or facilitate validation and 21 CFR Part 11 training

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.

Requirements

4 – 8 years of CSV experience in FDA regulated industry
BS degree in Computer Science, Life Science, or Engineering
Experience in the review, evaluation and testing of systems to ensure compliance with the FDA Electronic Records/Electronic Signatures regulation and 21 CFR
Good communication/interpersonal skills

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