What Youll Do
Project Phase (Through Mid-2025)
Supports Factory Acceptance Testing (FAT) at the vendor site as required
Supports Site acceptance Installation Verification (IV) Operational Verification (OV) and Performance Qualification (PQ) testing including protocol generation as applicable
Performs other operational readiness tasks as required such as: document review/approval team onboarding and materials management
Supervises manufacturing associates on technical and operational topics such as: area unit operations and equipment
Enforces company policies (e.g. travel & expense time reporting and time off that directly impact employees)
Leads peer department management in tactical and strategic development
Coaches direct reports to foster individual and team professional development and growth
Supports and leads water and engineering batch schedule attainment
Collaborates with partners vendors and key stakeholders as needed
Other duties as assigned
Operations Phase (Starting Mid-2025)
Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
Coordinates the execution of the manufacturing schedule through daily shift assignments lead daily huddles and manages escalations
Fosters an inclusive people-first culture with regular communication conducting 1:1s on a defined cadence with direct reports
Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
Supports manufacturing investigations and continuous improvement projects
Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment such as but not limited to: maintenance calibration activities and the use of manufacturing equipment
Administers company policies such as but not limited to: time reporting time off shift policies and inclement weather that directly impact manufacturing employees
Coaches and guides direct reports to foster individual and team 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
Leads peer department management in tactical and strategic development
Supports and leads water and engineering batch schedule attainment as required for the tech transfer of new products
Collaborates with partners vendors and key stakeholders as needed while executing the day-to-day manufacturing activities
Other duties as assigned
Basic Requirements
High School Diploma/GED with 8 years of related experience; OR
Bachelors degree in Life Science Engineering or related field with 4 years of related experience; OR
Masters degree in Life Science Engineering or related field with 2 years of related experience
2 years of experience managing a team
Experience with regulatory inspections investigations and change management
Preferred Requirements
Experience leading a team in a pharmaceutical or biological manufacturing operations
Experience working in a changing and project driven organization
Previous experience directly supporting manufacturing
Lean Six Sigma or similar certification
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
- Ability to discern audible cues
- Ability to ascend or descend ladders scaffolding ramps etc
- Ability to stand for prolonged periods of time - Up to 240 Minutes
- Ability to sit for prolonged periods of time - Up to 120 Minutes
- Ability to conduct activities using repetitive motions that include wrists hands and/or fingers
- Ability to conduct work that includes moving objects up to 33 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
- 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.