The Sr. Validation Engineer is responsible for the theory and content of validation documents for new equipment/ facilities/ utilities/ processes/ control systems/ software, 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, they are responsible for planning, tracking and reporting on major review/revalidation activities. Assumes the supervisory responsibilities of reporting technicians. Serves in the role of Validation Manger or Section Manager in their absence.
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.
• Present or 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.
• 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.
• Plan and lead revalidation of existing plant equipment, facilities, utilities, processes, control systems, software, cleaning, etc.
• 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.
• Supervise validation technician(s) and validation consultants to provide project and technical direction, as needed.
• Provides technical training in validation to plant personnel.
• Write or 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
• Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications:
• Must have thorough knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Expertise in one of the following disciplines is required: manufacturing, facilities/utilities, laboratory, solution processes, sterilization, and/or controls systems/software.
• Must have good organizational, presentation, meeting facilitation and technical writing skills.
• Working knowledge of statistics is preferred.
• A minimum of two (2) years of supervisory experience is required.
• Requires a high level of resourcefulness, an 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 ICU Medical Specification Systems.
• A high level of attention to details and the ability to proofread and audit validation documents is required.
• Must be able to work weekends and holidays as required to meet deadlines.
• Must be able to manage complex projects, set/achieve timelines, direct/redirect resources and manage assigned funding.
Education and Experience:
• Bachelor’s Degree is required: Engineering (Mechanical, Chemical, Electrical, Biomedical, or related science).
• Incumbent must have a minimum of five years’ experience in a pharmaceutical GMP environment. Must have a minimum of two years direct validation experience.
• Candidates with other technical Bachelor’s degrees will be considered if they have four or more years of direct validation experience.
• Must have experience talking/dealing with regulatory and third party representatives.
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check
• Typically requires travel less than 5% of the time
Physical Requirements and Work Environment:
• Generally an office environment. Some physical demands when working on the manufacturing floor executing validation runs.
• Must be able to lift up to 25 lbs. unassisted.