Principal Validation Project Manager

  The Validation Project Manager will be responsible for managing the execution of multiple Computer Systems validation (CSV) and Data Integrity (DI) related projects at FDBT facilities. Support the Director of Validation by ensuring effective implementation and maintenance of the CSV and DI program. Serve as a CSV subject matter expert, and track and report action plan status/ completion as relates to CSV/DI validation systems improvement efforts.

External US

Essential Functions:

• Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals
• Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols and SOPs as required to meet 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements among others
• Works with CSV/DI Gap Assessments and Remediation Plans applying risk management principles
• Supports regulatory and client audits as CSV subject matter expert
• Able to work independently (author protocol, execute studies, analyze data, author reports)
• Ability to handle large, complex projects with minimum oversight
• Advanced knowledge of CSV/DI Program, able to discuss regulatory expectations for CSV/DI validation activities, program and documentation
• Demonstrated ability for planning and organizing CSV/DI projects and day to day activities with cross functional groups and providing status updates for CSV/DI validation projects day-to-day activities
• Ability to assess large and complex change controls with an accurate understanding of the bigger picture implications of changes, with minimum input from Director of Validations
• Capable discussing CSV/DI validation programmatic Scope during customer audits or regulatory inspections, and address questions about day-to-day activities in order to mentor and guide Validation Engineer I-III level personnel
• Coordinate resources and personnel to achieve company and department goals
• Pre-approve and post-approve CSV/DI qualification protocols
• Execute CSV/DI validation protocols (when required)
• Prepares CSV Validation Project Plans as applicable
• Approves the resolution of discrepancies encountered during protocol execution
• Approves qualification summary reports
• Investigate and close-out exception reports and non-conformances associated with validation studies
• Assist in continuous improvement for the department by evaluating CSV/DI systems to improve functionality and efficiency
• Performs other duties as needed

Required Skills & Abilities:

• Thorough knowledge of CSV validation life cycle per GAMP 5 guidelines, validation protocols generation and execution of manufacturing, laboratory equipment and enterprise systems such as LIMS, TRACKWISE, MODA, SAP and CMMS Systems
• Solid understanding of computer systems validation, Data Integrity and change management in the clinical and commercial pharmaceutical/biotech industry
• GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others
• Demonstrated experience in management of complex tasks and projects
• Presents clear and understandable directions and goals. Provides and implements resolutions to project and day to day challenges
• Prioritizes workload and project/day to day activities
• Strong organizational skills
• Problem Solver, Decision Maker and develop plans for assigned projects and day to day activities
• Identifies gaps and deficiencies and responds to correct/mitigate them. Interprets complex data and draws concise and correct conclusions
• writes complex CSV lifecycle documents procedures and reports
• Communicates expectations effectively to cross-functional members
• Resolve or avoids conflict through experience and mediation skills
• Working knowledge of Microsoft Office products (Project, Outlook, Word, Excel, PowerPoint)

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged sitting, some bending, stooping and stretching
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
• Operation of test equipment such as: thermal mapping equipment, fog machine, air sampling equipment
• Working on ladders
• Attendance is mandatory

Principal Validation Project Manager Minimum Qualifications:

• At least a Bachelor's Degree preferably in Engineering or Life Sciences and/or 15+ years of experience in validation and management of computerized systems and Data Integrity Projects with 10+ years in pharma/biotech industry minimum
• cGMP Experience

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.