Validation - Technician I
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 14, 2023
Job Description:
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 Validation Technician I, under close supervision, will be
responsible for execution of validation protocols for simple
Facilities, Utilities, Systems and Equipment (FUSE), primarily
focusing on validation execution of Temperature Controlled
Environments-TCEs (-20s, -80s, 2-8s, incubators).
External US
Essential Functions:
- 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.Qualifications:
- 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.Preferred Qualifications:
- Degree in Engineering Discipline or Science Discipline
- Previous cGMP experience
- Previous experience in validationJoin 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.
Keywords: FUJIFILM Holdings America Corporation, College Station , Validation - Technician I, Professions , College Station, Texas
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