Sr. Validation Engineer

Merck & Co.; College Station (TX); On-site; USD 90,000 - 128,000; Full time

Job summary

FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, TX is seeking a Sr. Validation Engineer to lead validation across the lifecycle for FUSE systems, including CD/IQ/OQ/PQ, and to ensure regulatory compliance within a manufacturing setting.

Role requires cross-functional collaboration, strong GMP knowledge, and mentoring of junior engineers. Experience with clean rooms, lab equipment, and temperature-controlled units is preferred; opportunity for professional growth and a

Qualifications

• Advanced knowledge of validation across CD/IQ/OQ/PQ and lifecycle documents.
• Experience with FUSE systems, clean rooms, sterilization and temperature-controlled units.
• Familiarity with GMP, GDP, GLP and 21 CFR Part 11/Part 21O.
• Proven ability to plan, execute and close mid-size validation projects.
• Experience mentoring junior validation engineers.

Responsibilities

• Lead validation projects and author protocols, reports and lifecycle documents.
• Coordinate cross-functional validation activities and status updates.
• Review SDLC deliverables for FUSE systems and ensure SOP compliance.
• Support technology transfers, new technology introductions, and product launches.
• Mentor and develop junior engineers and specialists.

Skills

Validation engineering

GxP knowledge

Project management

Mentoring

Regulatory compliance

Cross-functional collaboration

Education

Master's degree in Mechanical Engineering

Bachelor's degree in Mechanical Engineering

Tools

E-Val ProNalSuite

Kaye Systems

Job description

Position Overview

Sr. Validation Engineer for FUJIFILM Diosynth Biotechnologies Texas, LLC, located in College Station, TX.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Sr. Validation Engineer for FUJIFILM Diosynth Biotechnologies Texas, LLC, located in College Station, TX. Responsible for providing scientific and technical support of product launches, technology transfers, and new technology introduction to the FDBT site. Accountable for performing activities such as Cycle Development (CD), Commissioning and Qualification, Performance Qualification (PQ) / Periodic Reviews (PR) and will closely collaborate across the site and occasionally works with other network organizations. Creation of validation Life Cycle Documentation (URS, FRS, DS, and other engineering specifications as needed), Validation (VPP, IQ, OQ, PQ, System Impact Assessment, Requirements Traceability Matrix, Final Report, etc.) ensuring documents meet regulatory and procedural requirements. Obtain approvals for FUSE systems and relevant infrastructure deliverables. Experience in the areas of Facilities, Utilities, Systems and Equipment (FUSE) including Classified Clean Rooms, Clean Utilities, Laboratory Equipment (ie. HPLC, UPLCs, UVVis and pH meters), Single Use technology, Sterilization Equipment (Steam & VHP), Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators), as well as preparing validation final reports for the same. Experience in the use of temperatures mapping tools including E-Val ProNalSuite/ Kaye Systems, particle counters, manometers, tachometer, RTD's at minimum. Must possess at least 2 years of experience planning and managing projects. 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. Lead mid-size validation projects and Jr. Validation Engineers/Specialists, from generation of all validation life cycle documentation to execution, post approval and release of FUSE systems for manufacturing operations. Able to work independently with minimum guidance from Validation Manager/Validation Associate Director (author protocol, execute, analyze data, author reports). Review all FUSE System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs). Create, review, and update VPPs, SIAs, Risk Assessments, SOPs, forms, templates, documentation, and files. Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations and industry codes. Familiar with ISPE Baseline 5, Vol. 2 GMP, GDP, GLP practices including 21CFR Part11 & Part21 O, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP, ASME and ISPE guidelines- Commissioning and Qualification and FDA industry regulations.

Requirements

Master's degree in Mechanical Engineering or related engineering field and three years of experience as a validation engineer or related occupation in validation engineering OR Bachelors degree in Mechanical Engineering or closely related engineering field and five years of experience as a validation engineer or related occupation in validation engineering

Must possess three years of experience with a Master's and five years with Bachelor's in:

• Validation engineering in pharmaceutical, biotechnology, or related industry.
• Creating validation protocols, deviations, and validation summary reports; utilizing Validation Life Cycle Concept
• FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators)
• ISPE Baseline 5, Vol. 2 GMP, GDP, GLP practices including 21CFR Part11 & Part21 O, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP , ASME and ISPE guidelines- Commissioning and Qualification and FDA industry regulations.
• Single Use technology
• Sterilization with Steam/ VHP.
• Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters)
• Utilizing temperatures mapping tools including E-Val ProNalSuite/ Kaye Systems.

Must possess at least 2 years of experience managing projects.

Must possess experience mentoring or training validations engineers

Salary

$90,000- $127,500 year

EEO Information

Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).

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