Validation Specialist

Review and author documents for adherence to CSQ P/P and LSEF·Provide day to day oversight to ensure teams are sustaining compliance and meeting commitments·Practice risk management techniques and processes
·Drive rapid implementation of standardized processes within Solution Delivery and Production Support teams
·Coach/mentor key team members on quality CSV and SW engineering·Actively contribute to the shared knowledge of the validation team
·Tailor organizational tools to meet project needs·Gather project and process metrics.·Assist System Custodian with internal and external audits.Participate in peer review program, where appropriate
REQUIREMENTS
IT workflow / process knowledge, including systems development lifecycle, service delivery, and support experience·Demonstrated ability to work independently and take initiative·Excellent written and verbal communication skills·Demonstrated commitment to teamwork and the ability to positively influence and lead others, both formally and informally.·Excellent organization and self-management skillsFamiliarity with regulatory agencies and inspections·Basic understanding of software development methodologies (Waterfall, Navigator, FAST, etc.)·Working grasp of Corporate Quality PoliciesWorking knowledge of computer systems validation as applied in a regulated area·Clear communication skills and ability to explain CSV to those not trained in CSV concepts·Effective interpersonal skills and the ability to build collaborative relationships with peers, business partners, and management·Persuasive negotiation skills
Bachelor of Science Degree in Computer Science or equivalent field.·3-5 years experience in Information Technology or related technology·3-5 years in validation·FDA validation experience.·Broad applications experience a plus.
·Systems development experience a plus.