Validation engineer

Senior Validation Engineer

The Senior Validation Engineer, with minimal supervision, is a non-supervisory role and will be responsible for drafting Validation Project Plans (VPPs), System Impact Assessments (SIAs) and 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:

• 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 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.
• 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:

• Master's Degree in Engineering Discipline or Science Discipline and 3+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environment, OR;
• Bachelor's Degree and 5+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated 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 FDA-regulated 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 (2-8 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 fast-paced, state of the art, alternately research and customized manufacturing facility.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.