The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.

What You’ll Do

• Leads the Upstream and Downstream drug substance manufacturing validation engineering team, including activities from thaw through bulk fill
• Provides support and direction on commissioning and qualification by utilizing technical expertise
• Oversees and manages a team of experienced engineers supporting operations, technology transfers, and projects on time and within budget
• Drives project goals and deliverables to ensure the successful completion of the project phase through commercial manufacturing
• Fosters and sustains a people first culture where the team feels valued, respected, and supported through servant leadership
• Creates and implements the strategy for process equipment validation lifecycle, such as Validation Master Plan (VMP), in close collaboration with the technical subject matter expert (SME) network and Large-Scale Business Unit counterparts
• Manages departmental budget, systems, processes, and team schedules
• Provides leadership and direction to the site team to define the commissioning and qualification requirements for execution of client’s processes
• Partners with Client, Process Engineering, Process Sciences, Quality, Manufacturing and Global Engineering on large-scale platform development, technology innovation, scale-up, and manufacturability as part of technology transfers, as needed
• Ensures that facilities, laboratory equipment, utility systems, and process equipment are maintained in a qualified and validated state
• Verifies and enforces that reports are written accurately and timely
• Establishes systems and procedures to enable period review, requalification, analysis, and reporting
• Delivers effective, engaging, and informative presentations, as needed
• Presents site validation programs to regulatory and other agencies, as necessary
• Provides team support for critical manufacturing investigations and technical oversight of deviations, change controls and corrective and preventive action (CAPA) regarding equipment qualification from Installation and Operational Performance Qualification
• Enforces and ensures team adheres to company policies
• Coaches and mentors’ direct reports to foster professional development and growth
• Participates in the recruitment process and retention strategies to attract and retain talent
• Addresses performance gaps, employee concerns, and partners with HR, as needed for resolution
• Other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in an Engineering discipline with 12 years of experience in a related engineering (e.g., validation) or another
similar role
• 2+ years of previous experience managing a team
• Experience working in a cGMP manufacturing facility

Preferred Requirements:

• Master’s degree in an Engineering discipline with 8 years of experience in a related engineering (e.g., validation) or another
similar role
• Prior experience working at a Greenfield site
• Large Capex experience
• Prior experience collaborating with global teams

 Working Conditions & Physical Requirements:

• Will work in environment which may necessitate respiratory protection.
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Will work in environment operating a motor vehicle or Powered Industrial Truck.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time, up to 120 minutes
• Ability to sit for prolonged periods of time, up to 120 minutes
• Ability to operate machinery and/or power tools.
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 50 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in warm/cold environments 0-110 F
• Will work in outdoor elements such as precipitation and wind.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

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.