Senior Manufacturing Process Engineer
Overview:
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities.Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
Summary:
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.
External US:
Essential Functions:
- 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.
Minimum Qualifications:
- Bachelor’s degree preferably in Science, Engineering, or other related field and with four (4) years of relevant experience; OR
- Associate’s degree preferably in Science, Engineering or other related field and six (6) years of relevant experience; OR
- High School/GED with eight (8) years of relevant experience.
- Above experience must include four (4) years GMP experience.
Preferred Qualifications:
- Experience in developing training materials.
- Experience conducting and evaluating training.
- Experience with laboratory and or manufacturing instruments/equipment.
- Previous leadership roles.
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
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 979-431-3500.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.