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Validation Engineer
Ref No.: 18-02996
Location: Irvine, California
 Position Summary
The Validation Engineer is responsible for the theory and content of validation documents for new equipment, facilities, utilities, processes, control systems, software, test equipment, changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with Plant and Corporate validation requirements and policies. In addition, assumes the supervisory responsibilities of reporting technicians.
Essential Duties & Responsibilities
  • Work closely with Validation Change Owners to plan, write and supporting execution of validation documents (IQ, OQ, IOQ, PQ etc.) compliant with Plant and Corporate policies and procedures; ensure proper execution/documentation of test results, and compilation of validation packages. Responsible for reviewing, executing and approving validation documents.
  • Work closely with the Validation Change Owners to present proposed validations to the Plant Validation Review Board and completed validations to regulatory and third party representatives during inspections and audits.
  • Serves as Change Owners for periodic reviews, process validation protocols, continued process verification protocols, and performance qualifications. Plans and/or executes these validation protocols.
  • Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriate.
  • Initiates, leads and authors cGMP risk assessment, gap analysis, and deviation management associated with validation programs with precise document writing following GDP with clarity to meet the set forth expectations
  • Ensure Validation Plans and strategies are in alignment with validation policies, procedures and guidelines and external regulatory requirements, and European and International standards.
  • Accountable for compliance of the site validation programs via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections.
  • Participate on investigation teams in the event of adverse validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving skills.
  • Perform validation sampling and data analysis of site processes.
  • Assist the Validation Change Owners with the process of obtaining validation package approvals.
  • Assist with the planning and tracking of the review or revalidation of existing plant equipment, facilities, utilities, processes, control systems, software, cleaning, etc.
  • Supervise validation technician(s) and testers to provide project and technical direction, as needed.
  • Assist with the writing of Standard Operating Procedures and Validation Master Plans.
  • Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies.
  • Assist with performing sterilization engineering assessments.
  • Work on special projects as they arise.
Knowledge, Skills & Qualifications
  • Must have thorough knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines.
  • Must have experience using validation protocols.
  • Must have good organizational and technical writing skills. Working knowledge of statistics is preferred.
  • Prior supervisory experience is desirable.
  • Responsible for evaluating equipment/facilities/utilities/processes/control systems/software processes to determine testing and documentation necessary to ensure FDA and industry compliance. Requires a high level of resourcefulness, and ability to get things done by removing obstacles, perceiving and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning.
  • Must maintain a thorough working knowledge of the Specification Systems.
  • A high level of attention to details and the ability to proofread and audit validation documents is required.
  • Must work overtime, weekends and holidays as required to meet deadlines.
Education And Experience
  • The position requires a Bachelor's Degree in Engineering or Science (Engineering preferred). (Candidates with other Bachelor's degrees will be considered if they have four (4) or more years of direct validation experience.) Incumbent must have a minimum of three (3) years' experience in a pharmaceutical GMP environment and two (2) years direct experience in some aspect of validation.
  • Experience in one of the following disciplines is required, and is dependent on where the opening exists: manufacturing, facilities/utilities, solution processes, sterilization, and/or controls systems software.