Manager, CQV

Position Overview

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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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 : Description

What Youll 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 clients 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 :

Bachelors 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 :

Masters 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 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.

EEO Information

Fujifilm is committedto 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.

ADA Information

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 ().

Required Experience :

Manager

Key Skills

Restaurant Experience,Customer Service,Employee Evaluation,Management Experience,Math,Employment & Labor Law,Sanitation,Leadership Experience,P&L Management,Mentoring,Supervising Experience,Restaurant Management

Employment Type : Unclear

Experience : years

Vacancy : 1