Validation Engineer I

Company: AGC Biologics
Location: Seattle
Posted on: June 25, 2022

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.SummaryAGC Biologics is seeking an energetic and enthusiastic individual with a strong background in Validation or Engineering in biotechnology and/ or pharmaceutical manufacturing to join the Validation Team within the Quality Group. This position will primarily contribute to the qualification/validation of facilities, utilities, laboratory equipment, and computer systems and the maintenance of a validated state for existing equipment. Additionally, this position will lead complex validation projects and teams.Principal Responsibilities

• Generate, review and execute qualification/validation documents for the qualification/validation of facilities, utilities, laboratory equipment, cleaning, and computer systems.
• Evaluate specifications to determine test scripts and acceptance criteria to demonstrate that the equipment is fit for its intended use.
• Perform validation impact assessments
• Investigate, resolve and close deviations and associated CAPAs.
• Generate and maintain validation templates, procedures, master plans and reports
• Apply risk analysis methods to validation
• Lead complex validation projects and teams
• Train and coach Validation Engineers in validation principles
• Generate and review Change Controls and SOPsKnowledge, Skills & Abilities
  • Excellent technical writing skills. In-depth knowledge of pharmaceutical processing. Qualification of facilities, utilities, manufacturing equipment and analytical equipment including automated equipment, validation of sterilization processes and IT-based computerized systems.
  • Proven expertise in planning/organization/execution of validation activities, following up on results and resolving complex problems with cross functional teams.
  • Ability to work hours necessary to support production and /or maintenance activitiesEducation/Experience
    • BS degree in Life Sciences, Engineering, or related discipline required.
    • 2 plus years' experience in a regulated pharmaceutical/medical technology environment required
    • Previous direct experience with regulatory inspections highly desirableAGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Keywords: AGC Biologics, Seattle , Validation Engineer I, Engineering , Seattle, Washington