Manufacturing Process Engineer I
4 weeks ago
The Manufacturing Process Engineer I is a key member of the Manufacturing Technical Operations department at FUJIFILM Holdings America Corporation. This role is responsible for providing expertise and assistance in the design, development, standardization, and maintenance of operational biotechnology used to manufacture various proteins and other drug substances.
Key Responsibilities- Work independently and with colleagues to provide expertise and assistance for the design, development, standardization, and maintenance of operational biotechnology used to manufacture various proteins and other drug substances.
- Develop and maintain equipment and unit operation standards and procedures utilizing the 4M (Man, Materials, Machinery, and Methods) approach.
- 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.
- 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.
- Bachelor's degree in Science, Engineering, or other related field and one (1) year of biotech manufacturing experience; OR
- Associate degree in Science, Engineering, or other related field and two (2) years of biotech manufacturing experience; OR
- High School/GED with four (4) years of biotech manufacturing experience
- All above must have one (1) year of GMP experience
- 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
- GMP experience
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