The Sr. Manufacturing Process Engineer is a mid-level position in the Manufacturing Technology Operations department in support of either the SATURN mAb or Gene Therapy manufacturing facilities located at the Texas BioManufacturing Facility – 100 (TBF – 100) or the Flexible Biomanufacturing Facility - 200 (FBF-200) respectively in College Station, Texas. The SATURN Platform utilizes entirely single use technology and is a multi-stream, multi-product facility that manufactures clinical and commercial products. The Gene Therapy operations at FBF-200 also utilizes single use technology in support of COVID-19 vaccine candidate manufacturing.
As a CDMO, customer liaison is a vital part of our business and the Technical Operations team act as the point of contact for our customers during manufacturing execution. This position will report directly to the Manager, Technical Operations, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
The Sr. Manufacturing Process Engineer works independently, with minimal supervision, and leads projects and colleagues to provide expertise and assistance for the design, development, standardization and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person will be the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.
- Responsible for specifying, purchasing, designing, qualifying, and handing over effective manufacturing systems ensuring plant modifications have credible delivery plans.
- Lead continuous improvement of materials to reduce risk and improve efficiencies.
- 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.
- Lead transfer and scale up of new processes and technologies to the manufacturing plant ensuring requirements for EHS and cGMP compliance.
- Manage the interface between Process Development and Manufacturing to ensure processes and transfers occur seamlessly and provide process engineering expertise to siting exercises placing new processes into the facility.
- Identify and lead change of technology transfer practices to deliver continuous improvements.
- Lead in the 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 such as deviations, QIPs, CAPAs, etc.
- Take the lead in investigating and resolving events that arise from compliance issues.
- Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach.
- All other duties as may be assigned.
Required Skills & Abilities
- 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.
- Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
- Excellent math and computer skills.
- Experience working in cleanroom environments.
- Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements
The physical demands described here 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. While performing the duties of this job, the employee is regularly required to
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use 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.
- Attendance is mandatory.
- Master's degree preferably in Science, Engineering, or other related field and with four (4) years' of relevant experience; OR
- Bachelor's degree preferably in Science, Engineering, or other related field and with six (6) years' of relevant experience; OR
- Associate's degree preferably in Science, Engineering or other related field and eight (8) years' of relevant experience; OR
- High School/GED with ten (10) years' of relevant experience.
- Above experience must include two (2) year GMP experience.
- Experience in developing training materials.
- Experience conducting and evaluating training.
- Experience with laboratory and or manufacturing instruments/equipment.
- Previous leadership roles.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.
If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.