CQV Engineer

3 weeks ago

Norwood, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Support qualification activities for facility and equipment
  • Provide technical and validation support for capital projects on site working with facilities, and manufacturing, Quality Control and Quality Assurance (QA) teams.
  • Lead validation activities and deliverables to meet the overall facility milestones.
  • Lead and support periodic assessment review and revalidation activities.
  • Oversee external contractors and vendors during commissioning and qualification.
  • Ensure deliverables are executed per 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, 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, 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:
  • minimum of 8 years of experience in biotech engineering or an FDA regulated manufacturing facility.
  • BS degree in engineering field or equivalent experience
  • Experience in cGMP facility/equipment start-up, commissioning, and qualification
  • 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.
  • bility to work on multiple tasks simultaneously.
  • bility to manage priorities, deliverables, and schedule milestones.
  • Requires strong interpersonal, verbal communication, and technical writing skills.
  • bility to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

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