Principal Engineering Manager - Process Engineering
Principal Engineering Manager - Process Engineering
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1 Vacancy
Job Description
Position Overview
The Principal Engineering Manager at Fujifilm Diosynth Biotechnology Texas (FDBT) plays a crucial role under the guidance of the Director of Engineering. This position oversees the Process Engineering team ensuring effective management of process engineering tasks such as equipment installation product introduction support and system assessments. Responsibilities include providing technical expertise and troubleshooting process equipment and utilities like bioreactors chillers boilers among others. Collaboration with various departments like facilities manufacturing QA/QC and contractors is vital for project implementation and maintenance of complex equipment.
Key duties involve leading process improvements through Change Control procedures implementing corrective and preventive actions via the CAPA system and guiding P&ID development SOP creation and equipment commissioning/qualification. The manager also identifies appropriate equipment specifications for future projects.
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 FUJIFILM Diosynth Biotechnologies 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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.
Job Description
Essential Functions:
- Manage and provide strategic oversight and effective leadership to the process engineering team.
- Direct process engineering staff on implementing process equipment site utilities and new technologies.
- Provide strategic oversight of engineering activities troubleshooting support and technical expertise for process equipment and site utilities.
- Facilitate technology and manufacturing program development in support of specific clients and market opportunities.
- Lead new product introductions (NPIs) from the infrastructure and process equipment perspective.
- Support client quality and regulatory audits and inspections.
- Lead and manage new equipment/systems installation including infrastructure connectivity and capability assessments.
- Implement solutions to engineering problems and/or opportunities and apply technical expertise to develop and present feasible solutions.
- Lead and train direct reports in developing change controls for the implementation of new system/equipment installations process improvements and site utilities.
- Identify new equipment specifications including type size materials operational conditions required utilities and user requirements specifications (URS).
- Collaborate with process sciences in developing equipment/systems/process design controls requirements specifications and drawings.
- Liaise with the CAPEX team for the implementation of capital projects.
- Direct lead and develop engineering staff on process/utilities equipment and new technologies.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Collaborate effectively with contractors manufacturing and quality control.
- Communicate efficiently with both internal and external stakeholders.
- Support proper testing validation and compliance with regulations.
- Develop and review SOPs and maintenance procedures.
- Ensure compliance with cGMP FDA and EHS guidelines.
- Maintain a safe work environment and adhere to safety protocols.
- Demonstrate leadership and mentorship skills.
- Identify and solve engineering problems efficiently.
- Manage multiple projects and priorities effectively.
- Proficient in project management software and MS Office Suite.
- Strong analytical and problemsolving abilities.
- Communicate technical information clearly to various audiences.
- Selfmotivated and adaptable in fastpaced settings.
- Pursue continuous improvement and learning.
- Knowledge of biomedical/biotechnical equipment and regulatory standards.
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:
- Engage in prolonged periods of sitting standing walking bending stooping and stretching.
- Utilize handeye coordination and manual dexterity to operate portable tools test instruments computer keyboard telephone calculator and other office equipment.
- Regularly lift and move objects weighing up to 50 pounds.
- Climb ladders and stairs of varying heights.
- Work under conditions that may be wet or humid.
- Provide support during off shifts weekends and holidays as needed.
- Work in outdoor weather conditions and noisy environments.
- Offer 24/7 support for company activities.
- Maintain mandatory attendance.
Minimum Qualifications:
- Bachelors degree in engineering with ten (10) to fourteen (14) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent preferably regulated by FDA or any other regulatory agency; OR
- Masters degree in engineering with eight (8) to twelve (12) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent preferably regulated by FDA or any other regulatory agency
- A minimum of four (4) or more years of previous leadership experience.
Preferred Qualifications:
- Knowledge of bioprocessing equipment clean utilities and single use equipment
- Knowledge of single use technology
- Knowledge of quality management software specifically Trackwise.
- Knowledge of both Upstream and Downstream processes.
- Engineering degree preferably in Mechanical Chemical Electrical or Biomedical Engineering.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or (979)).
Required Experience:
Manager
Employment Type
Unclear
