The Role

ElevateBio is looking to hire a Validation Engineer I to join the Validation Engineering. The Validation Engineer I will perform qualification activities for the manufacturing facility, utilities, equipment, and instruments. The Validation Engineer I will provide validation support for technical transfer, capital projects and ongoing validation improvement projects on site working with Facilities, Capital Projects Engineering, Process Engineering, Manufacturing, Quality Control and Quality Assurance (QA) teams.

Here’s What You’ll Do

• Independently perform validation activities including installation qualification, operational qualification, performance qualification for BaseCamp projects related to facility, utilities, equipment and instrument
• Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution
• Ensure deliverables meet the overall facility milestones
• Perform and support periodic assessment review and revalidation activities
• 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)
• Perform system impact assessments, risk assessments
• Support development and review of engineering lifecycle documents for new and existing equipment
• Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs
• Support validation activities related to tech transfer projects for all manufacturing suites
• Support site capital projects and other improvement projects
• Promote 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

• Bachelor’s degree in engineering or related field and at least 5 years of experience, OR Master’s degree with at least 3 years of related experience, OR PhD with at least 1 year of 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 in using Kneat is a plus
• Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories
• Required experience with good documentation practices and cGMP standards
• Ability to work on multiple tasks simultaneously
• Ability to manage priorities, deliverables, and schedule milestones
• Strong interpersonal, verbal communication, and technical writing skills

Physical and Environment Requirements:

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to lift 15-20 lbs
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $105,000 - $145,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.