The Validation Engineer / Senior Validation Engineer position is responsible for defining validation strategy and coordinating Validation activities required to complete assigned validation projects in support of the operation of the Vacaville Commercial Manufacturing Facility. An ideal candidate would have previous experience with the performance of such validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire.
Responsibilities of the Position:
Responsible for oversight and performance of Commissioning and Qualification of equipment, utility systems, automation systems, processes and facilities.
Leads efforts by representing the department on project teams and coordinates activities of MSAT, Manufacturing, Quality, and other Vacaville groups required to manage projects.
Prepare specific validation summary sections of regulatory submissions and present equipment validation packages to regulatory authorities during routine and pre-approval inspections.
Leads/participates in resolutions to regulatory observations through the CAPA system.
Leads the efforts to evaluate gaps, develop remediation plans and driving remediation through the CAPA system for the role out of new/revised Roche PQS requirements.
Prepares/Updates Validation Master Plans, Project Plans, and Protocols; Commissioning Plans, performs testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.
Peer Reviews/Approves Validation Protocols, Commissioning Plans, analyzes and approves test results, and approves summary reports generated by junior and contract personnel.
Promotes good interdepartmental relations.
Maintain Training to ensure job responsibilities can be performed on a daily basis.
Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.
Provide leadership to group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Vigilant to safety and maintains a safe environment for all during performance of job responsibilities (i.e. Validation Field Execution).
Minimum of 4 years (Validation Engineer E2) / 8 years (Sr. Validation Engineer E3) of direct validation experience and/or GMP operations experience with increasing levels of responsibility for a wide range of validation projects including validation of large scale biochemical manufacturing equipment, facilities, utility and automation systems.
Bachelors degree (Engineering, Life Science, Biology, Biochemistry) - recommended
Strong technical writing, verbal communication, interpersonal and problem solving skills.
Proficient / Thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
Ability to work independently, organize and manage individual as well as lead larger scale projects.