Commissioning, Qualification, and Validation Engineer GNE Parkville Australia ZOECQVEng260825

6 days ago

Parkville, Victoria, Australia Zoetis Full time $100,000 - $140,000 per year

POSITION SUMMARY

The CQV Engineer is responsible for qualifying new, existing, and upgraded systems, equipment, and facilities in a GMP-regulated environment.producing biological vaccines. This hybrid role involves leading validation and qualification efforts while also serving as a hands-on resource for executing qualification activities. The incumbent will participate, lead, and collaborate with various committees, including biosafety, site validation, site quality council, and EHS.

POSITION RESPONSIBILITIES

Validation and Qualification Leadership (40%)

  • Lead validation and qualification efforts for new, existing, and upgraded systems, equipment, and facilities.

  • Develop and implement validation master plans, protocols, and reports in compliance with GMP standards.

  • Coordinate and oversee validation activities, ensuring timely completion and adherence to regulatory requirements.

  • Participate on capital project teams to provide commissioning, qualification and validation expertise through all project phases.

Hands-On Execution of Qualification Activities (30%)

  • Execute qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

  • Execute revalidation activities for existing equipment.

  • Support third party contractor executing qualification and revalidation activities.

  • Perform risk assessments and develop mitigation strategies for validation projects.

  • Conduct testing and data analysis to ensure systems and equipment meet predefined acceptance criteria.

Committee Participation and Collaboration (20%)

  • Participate in and lead various committees, including biosafety, site validation, site quality council, and EHS.

  • Collaborate with cross-functional teams to ensure alignment and integration of validation activities with overall site operations.

  • Provide technical expertise and support to project teams and stakeholders.

Compliance and Documentation (10%)

  • Ensure all validation and qualification activities comply with GMP standards and regulatory requirements.

  • Maintain accurate and up-to-date documentation, including validation protocols, reports, and standard operating procedures (SOPs).

  • Support internal and external audits by providing necessary documentation and expertise.

  • Provide training and support to production and maintenance staff on commissioning, qualification and validation systems.

EDUCATION AND EXPERIENCE

  • Minimum education of a bachelor's degree in engineering, life sciences, or a related field.
  • 5-7 years of relevant experience in validation and qualification within a GMP-regulated environment.
  • Experience with biological vaccine production and aseptic/sterile manufacturing processes is highly desirable.

TECHNICAL SKILLS REQUIREMENTS

  • Proficiency in validation and qualification methodologies, including IQ, OQ, and PQ.
  • Strong understanding of GMP standards and regulatory requirements for pharmaceutical manufacturing.
  • Excellent problem-solving and troubleshooting skills.
  • Strong communication and documentation skills.
  • Ability to work effectively in a team-oriented environment.
  • Effective leadership skills and experience working in cross-functional teams.
  • Strong commitment to service and quality.
  • Ability to navigate & operate virtual meetings in various platforms.
  • Financial & budgeting skills.
  • Proficient in English, both oral and written, with sound technical writing skills.

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