Senior Manager, Engineering & Validation

Fujifilm•Morrisville, NC

17h•Hybrid

About The Position

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

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.
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
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

Nice To Haves

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

Responsibilities

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