FUJIFILM Holdings America Corporation · 1 day ago
Manufacturing Process Engineer II
US-TX-College Station
Full-time
Hybrid
Entry, Mid Level
2+ years expFUJIFILM Biotechnologies is seeking a Manufacturing Process Engineer II to join their Manufacturing Technical Operations department in College Station, Texas. The role involves providing expertise in the design, development, and maintenance of biotechnology operations for manufacturing various proteins and drug substances, as well as training manufacturing technicians.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Develop and maintain equipment and unit operation standards and procedures utilizing the 4M (Man, Materials, Machinery, and Methods) approach, including:
(Man) Develop and deliver practical skill-building and training plans for a given operational technology to manufacturing technicians
Collaborate with individuals and teams of technicians & managers on self-development plans
Responsible for interfacing with internal/external technical experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact the biopharmaceutical business, enabling technology options to be identified, evaluated and compared
Responsible for specifying, purchasing, designing, qualifying, and handing over effective manufacturing systems, ensuring plant modifications have credible delivery plans
Implement e-learning, video, classroom, and in-suite design and delivery as appropriate
Take the lead in investigating and resolving events that arise from compliance issues
Assist in identifying improvement to and managing change in technology transfer practices to deliver continuous improvements
Create and maintain the technical training manuals and personnel certification process
Develop and ensure training and skill-building activities align to site business requirements
Assure local operational practice reflect local procedure and instruction
Provide guidance and direction on cross-functional training initiatives
(Materials) Understand process control and material inputs to ensure capable and acceptable process output
Ensure supplies are in place to execute water runs and Engineering Test Plans/Studies
(Machinery) Understand technology operation capabilities, limits, and control strategies
Review and/or Approve equipment qualification limits
Review Calibration Tolerances and Approve Out of Tolerance Investigations
Coordinate validation, calibration, and PM completion of manufacturing lab equipment
Creation and or revision of recipes or methods for various platforms
Represent the manufacturing unit for equipment purchase, new technology, and changes to equipment
(Methods) Develop and maintain Technical Operational Manuals/Standard Operating Procedures/Work Instructions/Batch Records
Lead operational technology standardization, standard batch templates, and instruction interfaces and lead continuous improvement for a given technology
Assist in transferring and scaling new processes and technologies to the manufacturing plant, ensuring requirements for EHS and cGMP compliance
Ensure procedures are in place to execute water runs and Engineering Test Plans/Studies
Interface with Process Development and Process Science to ensure a smooth transfer of processes into the manufacturing plant
Develop and approve procedures and batch records
Author URS (user requirement specification) documents
Ensure best practice operating methods are deployed and assist in resolving operational problems such as deviations, QIPs, CAPAs, change controls, etc
Review and approve batch records, process validation protocols, process specifications, BOMs, campaign summary reports, and other documentation
All other duties as may be assigned
Qualification
Required
Bachelor's degree in Science, Engineering, or other related field and two (2) years of biotech manufacturing experience; OR
Associate degree in Science, Engineering, or other related field and four (4) years of biotech manufacturing experience; OR
High School/GED with six (6) years of biotech manufacturing experience
All above must have two (2) years of GMP experience
Excellent oral and written communication skills and interpersonal and organizational skills
Strong leadership skills
Ability to train others to perform to cGMP standards
Proficient with Microsoft Office applications
Good self-discipline and attention to detail; ability to work under minimal supervision
Must have flexible work hours – willing to work outside of normally-scheduled hours, including opportunities for alternative shift hours and weekends as required
Experience working in cleanroom environments under sterile or aseptic conditions; must have experience in engineering standards required for this type of operation
Must have good planning skills and be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities
Preferred
Previous Process Engineering experience
Experience in developing training materials
Experience conducting and evaluating training
Experience with laboratory and or manufacturing instruments/equipment
Previous leadership roles
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase