Validation Manager
Validation Manager
Duties:
Supervise technical teams and interface with clients to understand their needs regarding Chemistry Testing, developing project level effort estimates for proposals. Lead Validation Projects and manage the validation lifecycle of computer systems, including planning, executing, and documenting validation activities in accordance with regulatory requirements and company policies. Perform Requirements elicitation for Chemical Laboratory Systems to ensure data quality and integrity within laboratory workflows. Author cGxP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans, and other validation deliverables as required to help clients prepare for and defend against regulatory audits. Author, review, and approve validation documentation aimed at confirming that systems in Chemical Laboratories perform their functions as intended by users. Provide support, direction, and strategy for one or more validation projects, acting as the primary Subject Matter Expert (SME) for systems validation in Chemical Laboratories. Apply expertise in GAMP5 guidelines to develop and maintain validation strategies, protocols, and documentation for chemical laboratory systems, ensuring compliance with regulatory standards. Identify, assess, and mitigate risks associated with computer systems used in chemical laboratory settings, implementing appropriate controls and validation practices to ensure data integrity and reliability. Collaborate closely with chemical laboratory personnel, IT professionals, quality assurance teams, and other stakeholders to facilitate effective communication and alignment of validation efforts with business objectives. Provide guidance and training to chemical laboratory staff on CSV principles, procedures, and best practices to foster a culture of compliance and continuous improvement
Requirements: Bachelor's in chemistry or related field. Must have 2 years' experience with computer systems validation within the pharmaceutical or chemical industry, with a focus on laboratory systems. Must have skills with GAMP5 guidelines and regulatory requirements, chemical laboratory workflows, instrumentation, and data management processes
Pay: $152,859 per year