Senior Validation Engineer

The Role:

The Senior Validation Engineer will report directly to Director of Capital Projects and have overall responsibility for developing and executing the commissioning, qualification, and validation of our new state-of-the-art BaseCamp Pittsburgh Cell Therapy Manufacturing facility to be located in Pittsburg, PA. The Senor Validation Engineer will provide technical and validation support for capital projects on site working with facilities, manufacturing, Quality Control and Quality Assurance (QA) teams.

Here’s What You’ll Do:

• Ensure adherence to a commissioning and qualification schedule and Validation Project plan for the facility, utilities, process, and analytical equipment
• Review and approval of commissioning and qualification protocols and reports for facility, utilities, process, and analytical equipment
• Review and approval of change controls to release facilities, utilities, process, and analytical equipment for GMP manufacturing use.
• Lead validation activities and deliverables to meet the overall facility milestones.
• Oversee external contractors and vendors during commissioning and qualification.
• Develop URS/Validation and equipment documentation (risk assessments URS, FAT/SAT, IOQ, SOPs, etc.), to support new facilities and equipment.
• Ensure deliverables are executed per ElevateBio Validation Master Plan and other required SOPs.
• Ensure discrepancies are resolved and closed out in a timely manner.
• Develop testing templates and qualification protocols using paper and electronic validation systems (KNEAT)
• Creation and review of high-level documentation such as VMPs, risk assessments, System Level Impact Assessments, criticality assessments, quality plans, commissioning plans, etc.
• Perform system impact assessments, risk assessments, and traceability matrices.
• Support development of engineering lifecycle documents for new equipment
• Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs.
• Support site capital projects and other improvement projects
• Promotes engineering best practices, Elevate SOPs, and cGMP regulations.
• Work with Quality Assurance to ensure all validation activities are in compliance.
• Support and execute Change Controls to qualified facilities, equipment, and utilities

Requirements:

• 8+ years of experience in biotech engineering or an FDA regulated manufacturing facility.
• Bachelor’s degree in engineering, or a related discipline and experience.
• Experience in cGMP facility/equipment start-up, commissioning, and qualification
• Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish. Viral vector & Cell/Gene Therapies experience is a plus.
• Experience using KNEAT is preferred.
• Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment, systems and QC laboratories
• Strong interpersonal communication skills and ability to work effectively with internal cross functional teams, vendors, and contract resources.
• Proficient at applying good engineering practices, industry guidance (ISPE, ISO, GAMP) and regulatory requirements (EU, JP, CFR 210, 211, Part 11)
• Required experience with good documentation practices, technical writing, and cGMP standards.
• Ability to manage priorities, deliverables, and schedule milestones.
• Proficiency with Procore, Smartsheet, Microsoft Project, Bluebeam Revu is a plus.