Validation Engineer III

FUJIFILM; College Station (TX); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company dedicated to advancing tomorrow’s medicine! As a Validation Engineer III, you'll play a crucial role in ensuring the integrity of validation protocols for state-of-the-art facilities and systems. This position offers a unique opportunity to collaborate with cross-functional teams and contribute to groundbreaking projects in the biopharma industry. With a culture that fosters passion and innovation, you'll be empowered to chase the impossible and expand your potential while making a real difference in people's lives. If you're ready to take on this exciting challenge, we want to hear from you!

Qualifications

• 2+ years of experience in validation in FDA-regulated environments.
• Strong knowledge of FUSE systems and engineering principles.
• Ability to work with minimal guidance in a fast-paced environment.

Responsibilities

• Draft and execute validation protocols for Facilities, Utilities, Systems, and Equipment.
• Plan and organize validation activities among cross-functional groups.
• Review and update SOPs and validation deliverables.

Skills

Validation in Pharmaceutical Industry

Regulatory Compliance

Engineering Principles

Microsoft Office

Communication Skills

Education

Master's Degree

Bachelor's Degree

Associate's Degree

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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.

External US

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.

The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.

Reports to

Associate Director, Validation

Work Location

College Station, TX

Primary Responsibilities:

1. Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements.
2. Under guidance from Validation Engineers-Specialists /Validation Manager, plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
3. 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).
4. Must be able to review, and update SOPs, forms, templates, documentation, and files.
5. Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
6. Perform other duties as assigned.

Qualifications:

1. Master’s Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environment, OR;
2. Bachelor’s Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
3. Associates Degree with six 6+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
4. Degree in Engineering or Science Discipline preferred.
5. Significant working knowledge of engineering principles.
6. Strong working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.
7. Efficient Knowledge ISPE Baseline 5, Vol. 2 – Commissioning and Qualification and FDA industry regulations.
8. Solid written and oral communication skills.
9. Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
10. Ability to work with general guidance from Sr. Validation Engineers-Specialists /Validation Manager.
11. Able to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
12. 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:

1. Experience prolonged standing, some bending, stooping and stretching.
2. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
3. The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
4. Attendance is mandatory.

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 [e-mail] or call 979-431-3500.

About the company

Fujifilm's principal activities are the development, production, sale and servicing of business document solutions, medical imaging and diagnostics equipment, cosmetics, regenerative medicine, stem cells, biologics manufacturing, optical films for flat...