Sr. Validation Engineer

3 weeks ago

Lakewood, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Pharmaceutical facility and utilities, including: Classified areas, HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen.
  • Participate in Engineering, Qualification and Validation efforts within Renaissance Lakewood manufacturing, and facility support systems. Support development and enhancement of Equipment Facility and Utility qualification programs in accordance with current data integrity and cGMP best practice expectations. Oversee management of qualification protocol development. Oversee applicable computerized system administration. Ensure compliance with FDA, USP, EU, federal and state agencies, and applicable global health authorities.
  • Participate in development of risk based, quality driven procedures and practices with respect to engineering, qualification and validation. Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for the site.
  • Participate in the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.
  • ssist in the identification, development, and implementation of new technologies to meet best practice expectations in the Manufacturing and Laboratory environments. Provide technical support for system owners and administrators for various facility systems, manufacturing equipment, and laboratory instruments.
  • Support the change control program with respect to facility, and equipment changes. Support the Information Technology change control program for computerized systems.
  • Support the investigations program with respect to engineering, and qualification, related investigations, including trending and corrective and/or preventative actions.
  • Ensure audit readiness in areas of responsibility at all times. Act as a subject matter export during internal, Global Quality, third party, and health authority audits. As directed and when needed, interact with auditors to explain and/or clarify policies, procedures, and examples of equipment and computerized validations.
  • Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, utility and equipment qualification.
  • Perform technical review of qualification related documentation. Provide training/guidance to Quality, Maintenance/Engineering, Manufacturing, and Laboratory personnel on relevant policies and SOPs.
  • Collect and tabulate data, review data for errors and discrepancies, perform statistical analysis wherever appropriate and transcribe results into final reports.
  • Generate, review and approve qualification/validation procedures.
  • Generate final reports, compile historical data packages, and route documents for approval.
  • Review and approve set-up and operation procedures for production and packaging equipment.
  • Generate risk assessments and technical memorandums to discuss the approach to qualification related activities.
  • Support the rationale for the sample size selection during process equipment qualification.
  • Review and complete assigned Change Control tasks.
Requirements:
  • Bachelor's Degree in Engineering, Life Sciences or related discipline, with a minimum of 5 years of relevant experience performing validation activities within pharmaceutical environment; or equivalent combination of education and experience.
  • Must possess knowledge of and adhere to Company and departmental policies and procedures, as well as government regulations.
  • Must possess knowledge of current Good Manufacturing Practice (cGMPs), GAMP 5, 21CFR Part 210, Part 211, and Part 11. Knowledge of EudraLex - Volume 4 and World Health Organization (GMP) guidelines preferred.
  • background knowledge in pharmaceutical science or engineering, and equipment/computerized system validation is advantageous. Knowledge and understanding of pharmaceutical manufacturing equipment, facilities, and laboratory instrumentation preferred. Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control environments is advantageous.
  • Must possess excellent organizational and deductive reasoning skills.
  • Strong communication and written skills are required. Working knowledge of Trackwise, Documentum, and Microsoft Office, including Word and Excel is preferred. Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously. Must be able to work and interact well with other employees at all levels.

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