What Youll Do
Supports on time delivery and ensures quality from Fujifilm and Engineering Procurement Construction Management (EPCM) provider
Supports piping and instrumentation diagram (P&IDs) and other process design document review
Provides input to detailed design activities in partnership with EPCM provider
Writes User Requirement Specifications (URSs)
Supports Factory Acceptance Testing (FAT) Commissioning Qualification and Validation (CQV) and start-up activities with supervision
Serves as on-call support for process equipment
Reviews redlines and approves P&IDs and other technical documents with supervision
Contributes to system impact assessments and quality risk assessments for process equipment
Supports technology transfer (TT) activities related to process equipment
Supports execution of Good Manufacturing Practices (GMP) runs
Provides technical support for root cause analysis (RCA) and process deviation investigations
Assists with deviations change controls corrective and preventive action (CAPA) closures
Supports technical risk assessments for new manufacturing equipment
Provides on-floor manufacturing support for equipment issues
Cross-trains on unit operations to assist team with meeting deliverables
Collaborates with other departments such as Quality Manufacturing Maintenance Validation and Safety.
Other duties as assigned
Minimum Requirements
Bachelors degree in Chemical Engineering Biotechnology Engineering or another related field
0-1 years of engineering or other relevant technical work experience
Preferred Requirements
Experience working in a cGMP environment or other highly regulated industry
Prior experience with mammalian cell culture processes
Working & Physical Conditions
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 120 minutes.
Ability to sit for prolonged periods of time up to 240 minutes.
Ability to conduct activities using repetitive motions that include wrists hands or fingers.
Ability to operate machinery and/or power tools.
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 using twisting motions.
Will work in warm/cold environments (60-90 range).
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.