Validation - Technician I
- FUJIFILM Diosynth Biotechnologies
- College Station, TX
- Start date
- Mar 9, 2023
- Engineering, Process Engineer, Quality Engineer, Validation Engineer, Manufacturing & Production, Operations, Process
- Required Education
- High School or equivalent
- Position Type
- Full time
- Lone Star Bio
- Train on Temperature Mapping SOPs and equipment to become proficient in execution of Temperature Controlled Environment.
- Train and become efficient in validation execution of other simple Facilities, Utilities, Systems and Equipment (FUSE).
- Aid Validation Engineers/Specialist in obtaining pre-approvals/post-approvals of validation deliverables for FUSE systems and relevant infrastructure, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports.
- Attain knowledge of validation FUSE System Delivery Life Cycle (SDLC) deliverables, by training and understanding the program's Standard Operational Procedures (SOPs) and all documents and forms used to support the Validation Program. Consult with Validation Engineers-Specialists/Validation Managers for any clarification and guidance.
- Execute requalification protocols for TCEs and simple FUSE systems
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
- Perform other duties as assigned.
Required Skills & Abilities
- Ability learn/understand and work with technical testing equipment (computer parameters programing), sensors among others
- Ability to learn validation principles within a fast-paced environment under direct supervision of Sr. Validation Engineers-Specialists/Validation Managers.
- Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
- Good written and oral communication skills.
- Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
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 and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Working on ladders.
- Attendance is mandatory.
- Associates Degree
- Alternatively, High School Diploma and three (3) years of experience in a technical position within pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Degree in Engineering Discipline or Science Discipline
- Previous cGMP experience
- Previous experience in validation
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.
FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.
With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.
Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.
Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
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