The Validation Manager is the most senior level position within the Validation Team, which is part of the Engineering department of FDBU. The position ensures deliverables for the validation team are well established and in line with business needs and stakeholder expectations. The group consists of 4 – 6 FTE supporting equipment, computer system, and analytical instrument qualification along with oversight of validation contractors.
Reporting directly to the Director of Engineering, the Validation Manager leads the daily activities of the Validation team, including contractors, in support of 24-7 manufacturing operations. In addition, develop and execute efficient validation strategies that meet regulatory requirements and industry standards. Manage all aspects of the site validation lifecycle to assure Facilities, Utilities, Equipment, Instruments and Computerized Systems operate in a state of control consistently and reliably produce products that conform to specifications. Ensure changes in quality and regulatory compliance requirements are identified, documented, integrated, and maintained. Support innovation, continuous improvement, and harmonization of workflows, quality systems, and procedural guidance.
The Validation Manager will directly support or ensure support of capital projects in accordance with FDBU standards and cGMP regulatory requirements.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Lead the site Validation team to ensure that equipment and computer systems comply with cGMPs and corporate policies, and that quality documentation is complete and on time. Regulatory inspections are managed through satisfactory completion.
- Accountable for maintaining the site Master Validation Plan and inventory of site validations.
- Manage and maintain oversight of team and approve GXP Assessments for Facilities, Utilities, Manufacturing Equipment, and components to define the collective requirements for validation. Support corporate Data Integrity and CSV initiatives.
- Develop organizational capabilities to ensure continued staff development. In collaboration with the Validation leadership and site lead, develop functional goals, drive, and monitor performance against goals and KPIs.
- Collaborate with Engineering, MTS, QA, and Manufacturing functions to document equipment and process specifications and requirements. Work with other corporate validation management to execute validation programs.
- Participate and provide guidance for User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA).
- Provide direction and participate in validation protocol development/review and approval. Ensure that validation prerequisites have appropriately been conducted before validation execution.
- Lead the team to assess GMP changes to assure that the validated state and process control is maintained.
- Ensure appropriate staffing of team with validation subject matter experts. Provide ongoing coaching and mentoring to assure that team's competency remains current with changes in regulatory and industry standards.
- Assure consistent execution across the team to standardize approaches to Validation that are efficient, effective, and compliant. Provide training for other functions, as required, on validation requirements.
- As subject matter expert, interface with Regulatory agencies and clients, as required, in conjunction with new drug applications, Facility inspections, and technical interchanges to represent the company's validation position. Ensure timely closure of observations/audit items.
- Provide technical support in case of critical process-related deviations in root cause investigation and implementation of corrective and preventive actions.
- Support site Validation related activities for the design, commissioning, qualification, and continued Validation maintenance of all Process and Analytical Equipment, Computer Systems, Facilities, and Utilities, including identifying opportunities for improvement.
- Maintain departmental expertise in validation and related activities. Support DI and CSV initiatives.
- Ability to organize and present technical and project management overviews to engineering staff, cross functional departments, and management without assistance
- Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
- Maintains effective relationships across functional units gaining their trust and respect
- Puts accomplishing the goals of the team ahead of accomplishing individual goals
- Openly shares expertise with co-workers to help strengthen general knowledge and skills
- Solicits input/feedback from others beyond role or departmental boundaries as developmental opportunity
- Approaches situations objectively and is receptive to various viewpoints
- Exhibits professionalism and sets an example for others to follow
- Self-starter and detail oriented
- Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve
- Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action
- Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by nonautomation personnel
- Ability to lead teams with and without direct reporting structure while demonstrating influential leadership skills
- S. Degree in Engineering or related Life Sciences with 10+ years relevant experience or M.S with 7+ years relevant experience. Must include 5+ years direct validation experience.
- Proven track record of staff management, capable of developing people and teams with at least 5 years of management experience.
- Experience in the successful management of complex Validation activities. Familiarity with Quality Management Systems and GxP Regulations, including 21 CFR Part 11 for Data Integrity
- Working knowledge of risk assessment methodologies and practices, including prior experience using risk analysis for testing strategy development and justification.
- Sound industry knowledge, project proficiency, and autonomy are expected. May be considered a Subject Matter Expert (SME) in validation to support FDA PAI or other regulator/client inspections
- Must possess in-depth knowledge of bio-pharmaceutical equipment, Clean Utilities, and CSV.
- Hands-on experience and good working knowledge of equipment such as Bioreactors, Autoclaves, Washers, Environmental Chambers, Incubators, etc.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.