Manager, Validation

at  Thermo Fisher Scientific

POSITION SUMMARY

Lead a professional support staff and contractors responsible for validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries to include the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes (Including Smoke Study). Negotiate specific process validation criteria and required external resources. Coordinate interdepartmental process validation programs. Represent the department regarding process validation issues during FDA meetings and audits. Identify and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to senior management. Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promoting, disciplining and firing. Find opportunities and provide the means for employees to pursue career growth.

• Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best.
• Responsible for the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees. Handle designs, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information./automation validation.
• Develop, approve, implement, and present all validation master plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs. Represent the department during audits, meetings, and teleconferences regarding process validation issues with the FDA. Provide responses to FDA deficiency letters and audit observations.
• Lead multi-disciplinary validation teams, approve testing protocol and establish acceptance criteria for validation projects that impact on the production and control of externally produced products, both in clinical supply and trade product manufacturing. Negotiate the scheduling and dedication of specific resources outside the department required for validation projects.
• Audit, evaluate, and qualify all vendors or contractors. Negotiate validation requirements with these vendors. Plan and establish technical communications, document flow, testing requirements, and financial resources necessary to produce the validation of the system. Review and approve all vendor-supplied documents. Coordinate the audits of inter-departmental validation programs.
• Select bidders, award and coordinate contracts involving consulting, laboratory, and process validation engineering services. Prepare and defend five-year plans and annual budgets for the department by assessing staff and capital needs.
• Participate in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance as the validation representative on engineering project teams. Develop and maintain a plant wide change control system to review, authorize and document changes to validated systems.
• Provide process validation guidance to domestic contractors and other subsidiaries of the Company supplying US markets regarding current FDA requirements for facility and product approval. Determine FDA’s current regulatory policies regarding process validation of drug manufacturing for domestic and foreign sites and implement procedures accordingly.
• Represent the Company as an active participant on internal (GQD) and external (ISPE/PDA/PMA) professional committees establishing policy guidelines relating to validation issues.
• Follow all job-related safety and other training requirements.
• Perform other duties as assigned.