Sr. Validation Engineer

Fujifilm • College Station, TX

1d • $90,000 - $127,500 • Onsite

About The Position

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
• 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

Responsibilities

• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees