Senior Validation Engineer
Senior Validation Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
The Senior Validation Engineer with minimal supervision is a nonsupervisory role and will be responsible for drafting Validation Project Plans (VPPs) System Impact Assessment (SIAs) and drafting and executing validation protocols for Facilities Utilities Systems and Equipment (FUSE) as well as preparing validation final reports for the same.
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
Reports to Associate Director Validation
Work Location College Station TX
Primary Responsibilities:
- Generate VPPs SIAs obtain approvals and execute validation deliverables for FUSE systems and relevant infrastructure including Risk Assessments Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports ensuring documents meet regulatory and procedural requirements.
- Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to daytoday operations or project work.
- Lead midsize validation projects and Jr. Validation Engineers/Specialists from generation of all validation life cycle documentation to post approval and release of FUSE systems for manufacturing operations.
- Must be able to review all FUSE System Delivery Life Cycle (SDLC) deliverables provide constructive feedback and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
- Perform other duties as assigned.
Qualifications:
- Masters Degree in Engineering Discipline or Science Discipline and 3 years of direct Validation experience in pharmaceutical biotechnology or related industry preferably in FDAregulated environment OR;
- Bachelors Degree and 5 years of direct Validation experience in pharmaceutical biotechnology or related industry preferably in FDAregulated environment.
- Associate of Science Degree in Computer Science Life Sciences Engineering or similar discipline with 7 years of experience in computer system validation activities in pharmaceutical biotechnology or related industry preferably in FDAregulated environments.
- 2 years of lead experience or working with personnel indirectly in a project management role.
- Strong Working knowledge of engineering principles.
- Solid Working knowledge and expertise in FUSE Systems including Classified Clean Rooms Clean Utilities Sterilization Equipment Temperature Controlled Units 28 C 80 C LN2 Freezers Incubators) among others.
- Detailed Knowledge ISPE Baseline 5 Vol. 2 Commissioning and Qualification and FDA industry regulations.
- Excellent written and oral communication skills.
- Working knowledge and experience in Microsoft Office products (Outlook Word Excel Power Point).
- Ability to work with minimal supervision.
- Efficiently works in fastpaced state of the art alternately research and customized manufacturing facility.
- Role model for company core values of trust delighting our customers Gemba and Genki.
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 handeye 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.
Join us! FDB is advancing tomorrows 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.
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 viaemail 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.
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.
Required Experience:
Senior IC
Employment Type
Unclear
