This position is responsible for leading validation projects. Sr. Validation Engineer will be a senior member of the validation team developing, reviewing, executing and managing validation activities, and ensuring that the qualification / validation activities are consistent with user’s / manufacturer’s requirements and site quality standards.
This role will be responsible for validation activities such as : Lead equipment and utility validation projects and manage project schedule.
Act as technical lead for a cross-functional project and regularly interfaces with other groups to coordinate activities ensuring effective and clear communications.
Work with equipment vendors to define requirements and understand functional specifications.Represent validation program during audits and inspections.
Identifies and solves problems in experimental designs.Independently plans and designs experiments involving potentially conflicting design requirements.
Investigates, adapts, or modifies experimental methods and technologies for project advancement.Independently analyzes complex data, interprets results, and suggests next experiment.
Can act as technical lead for a cross-functional project and regularly interfaces with other groups to coordinate activities.
Interfaces and collaborates with other groups to solve technical problems; typically guides peers in troubleshooting efforts.
Maintains high level of expertise with relevant literature and guidance documents.Sources materials and resources internally / externally as needed for various projects.
Provides additional support and cross-trains as business needs ariseWho You AreMinimum QualificationsMaster’s Degree in Engineering, Biology, or related science discipline with 6+ years of experience in Biologics, Pharma, Device or Biotech OR a Bachelor Degree in Engineering, Biology, or related science discipline with 12+ years of experience in Biologics, Pharma, Device or Biotech.
8+ years of experience in DQ, IQ, OQ, PQ for lab and / or manufacturing equipment, facilities and utilities.8+ years of experience in temp.
mapping of CTUs, autoclaves etc.8+ years of experience in Asset management (BMRAM), temp. mapping and CSV projects per current requirements.
8+ years of experience of writing risk assessments per Quality Risk Management concepts and creating plans, protocols, reports and SOP’s for validation reports.
Preferred QualificationsExperience in Biologic manufacturing facility and site expansion.Experience with new facilities to support validation project from the site construction.
Understanding of principles and concepts of Lean Six Sigma to continuously improve qualification program.
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