Engineering Operations Manager
4 days ago
Role Overview
The Engineering Operations Manager will be responsible for providing expertise and assistance for the design, development, standardization, and maintenance of operational biotechnology used to manufacture various proteins and other drug substances. This role will also lead operational technology standardization, create and maintain technical training manuals, and ensure procedures are in place to execute water runs and engineering test plans/studies.
Key Responsibilities
- Develop and maintain equipment and unit operation standards and procedures utilizing the 4M approach
- Collaborate with individuals and teams on self-development plans and interface with internal/external technical experts to maintain knowledge of technology and regulatory issues
- Specify, purchase, design, qualify, and hand over effective manufacturing systems, ensuring plant modifications have credible delivery plans
- Implement e-learning, video, classroom, and in-suite training as appropriate and take the lead in investigating and resolving events that arise from compliance issues
- Create and maintain technical training manuals and personnel certification process
Requirements
- Bachelor's degree in Science, Engineering, or related field and two years of biotech manufacturing experience
- Excellent oral and written communication skills, strong leadership skills, and ability to train others to perform to cGMP standards
- Proficient with Microsoft Office applications and good self-discipline and attention to detail
- Experience working in cleanroom environments under sterile or aseptic conditions and good planning skills
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