Senior Manager, Engineering and Validation is recognized both as the technical subject matter expert and leader of the Engineering and Validation team at FLBU. The position will ensure that deliverables for the Engineering group are well established and in line with their stakeholders' expectations. The team consists of Process/Production and Validation engineers supporting Operations, as well as resources managing Engineering Document Control. Expectations of the position are to manage between 5-10 full-time employees as well as the contractors that support their efforts, establish expectations for the team, and provide direction for the activities that will support overall site goals.

Reporting directly to the Head of Engineering and Facilities, the Senior Manager, Engineering and Validation oversees the day-to-day activities of the Engineering group as well as the implementation of new technology and modifications to existing systems aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement. The team is responsible for supporting process equipment troubleshooting on the manufacturing floor during production, supporting new equipment introduction design aspects, validation activities around new equipment introduction and existing equipment re-qualifications, engineering document management, and operational and capital projects on site.

The team is responsible for processing equipment for fermentation and cell culture biologics processes, including upstream and downstream equipment, as well as support equipment such as Autoclaves, Glasswashers, etc., and the team should have expertise in these areas.

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

What You’ll Do

• Responsible for a team of Process/Production and Validation engineers and Engineering Document Control specialists in support of the site and departmental goals
• Develop and manage team member's performance and capabilities while providing formal and informal feedback to direct reports
• Assures team activities are carried out in a manner of compliance with FDBU standards and cGMP regulatory requirements
• Coaches team members in a learning culture with the goal of achieving employee empowerment and ownership
• Establishes team objectives and ensures alignment with site and departmental goals
• Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Automation, and Quality to deliver site goals and objectives
• Actively manage contractor activities to ensure work quality and safe practices to facilitate contractor training
• Provide training or presentations on automation systems and tasks to all site personnel
• Provide hands-on detailed diagnostics/troubleshooting support to manufacturing, development, and automated equipment
• Assess equipment and control systems to design and implement sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements While following GAMP guidelines
• Independently manage or provide the support required for capital projects from conception, design, and initial specifications through completion and turnover. This includes developing detailed and accurate project schedules while collaborating with internal cross-functional teams end users and third-party contacts to maintain project deliverables concurrently with a dynamic workload based on site priorities.
• Update and develop User Requirement Specification, Functional Specifications, Design Specifications, and Guidelines for new and existing equipment and control systems
• Generate and execute IOQs and PQs for new and revised processes and equipment
• Develop, mentor, and train team members on equipment functionality, troubleshooting, and diagnostic techniques to enhance the overall capability of the group
• Develop revise, and abide by standard operating procedures and engineering documents
• Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with processing equipment to properly identify root causes and implement appropriate corrective and preventative actions to prevent reoccurrence.
• Provide process and validation subject matter expertise for regulatory inspections and interact with auditors as required
• Other duties as assigned

Knowledge and Skills

• Thorough understanding of pharmaceutical processing equipment, knowledge in cell culture processing equipment preferred
• Demonstrated knowledge of cGMP practices and equipment lifecycle processes
• Knowledge of Commissioning, Qualification, and Validation best practices and functionality
• Working knowledge of process control and equipment automation in biotech or pharmaceutical manufacturing facility
• Display a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise (e.g., automation, manufacturing, quality, etc.)
• Solid understanding of relevant pharmaceutical PAT initiatives and the impact on regulatory guidelines
• Demonstrated project management skills for ensuring project delivery to customer expectations. schedule, and budget

Basic Requirements

• B.S. Degree in Chemical, Electrical, Mechanical, or similar Engineering with 10+ years' experience in relevant engineering and/or pharmaceutical manufacturing operations and 5+ years’ experience leading or managing people and teams.
• M.S. Degree in Chemical, Electrical, Mechanical, or similar Engineering with 7+ years' experience in relevant engineering and/or pharmaceutical manufacturing operations and 3+ years’ experience leading or managing people and teams.

Additional Requirements

• Demonstrated leadership, interpersonal technical aptitude, and problem-solving skills. Strong team-building skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.
• Flexible and able to manage multiple priorities and projects
• Results-driven and goal-oriented with the ability to manage risks
• Hands-on active management style while maintaining awareness of team activities
• Excellent organizational, verbal, and written communication skills with the ability to effectively communicate within cross-functional teams and with upper management
• Ability to organize and present technical overview to engineering staff, cross-functional departments, and upper management.
• Maintains effective relationships across functional units gaining their trust and respect
• Puts accomplishing the goals of the group ahead of accomplishing individual goals
• Openly shares knowledge/information needed to accomplish a task or solve a problem
• 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
• Ability to discuss normally encountered technical issues, both verbally and in writing, in a manner that is understood by non-technical personnel

Preferred Certifications:

• Project Management Professional (PMP)
• Lean/Six Sigma (Green/Black Belt)
• Professional Engineer (PE)

Working Conditions & Physical Requirements:

• The position requires essential physical abilities, including but not limited to stooping, kneeling, crouching, reaching, standing, walking, lifting, fingering, grasping, feeling, talking and hearing. The 1nd1v1dual may need to exert physical effort such as moving light objects up to 20 pounds occasionally, 10 pounds frequently, and/or a negligible amount constantly.
• The individual in this position should have the visual acuity required to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal: extensive reading: visual inspection involving minor defects, small parts, and/or using measurement devices at distances close to the eyes Additionally, this individual must have the visual acuity to determine the accuracy, neatness and thoroughness of work assigned or to make general observations of facilities or structures
• The individual in this position works in both environmental conditions: Actvities occur inside and outside

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.

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Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).