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Senior Manufacturing Process Engineer
4 weeks ago
We are seeking a highly skilled Senior Manufacturing Process Engineer to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our manufacturing team, you will be responsible for leading projects and collaborating with colleagues to design, develop, and standardize operational biotechnology used in the manufacture of proteins and drug substances.
Key Responsibilities- Specify, purchase, design, qualify, and hand over effective manufacturing systems, ensuring plant modifications have credible delivery plans.
- Lead continuous improvement of materials to reduce risk and improve efficiencies.
- Interface with internal and external technical experts and peers to maintain a broad knowledge of technology and regulatory issues impacting the biopharmaceutical business.
- Lead transfer and scale-up of new processes and technologies to the manufacturing plant, ensuring EHS and cGMP compliance.
- Manage the interface between Process Development and Manufacturing to ensure seamless processes and provide process engineering expertise for siting exercises.
- Identify and lead changes in technology transfer practices to deliver continuous improvements.
- Lead training and coaching of project team members to ensure technical and personal objectives are achieved within agreed time frames.
- Ensure best practice operating methods are deployed and assist in resolving operational problems.
- Take the lead in investigating and resolving events arising from compliance issues.
- Develop and maintain equipment and unit operation standards and procedures using the 4M approach.
- Bachelor's degree in Science, Engineering, or a related field, with four years of relevant experience, or an Associate's degree with six years of experience, or a High School/GED with eight years of experience.
- Four years of GMP experience.
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Excellent leadership skills.
- Ability to train others to perform to cGMP standards.
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail.
- Flexible work hours, with willingness to work outside of normally scheduled hours as necessary.
- Excellent math and computer skills.
- Experience working in cleanroom environments.
- Good planning skills and ability to interface with and guide colleagues in various roles and functions.
The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching.
- Use of hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
