Commissioning, Qualification, and Validation Engineer

About Zoetis

As the world's leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide – from livestock farmers to veterinarians and pet owners. The company's leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $7.8 billion in 2021 with approximately 12,100 employees. For more information, visit

Position summary

Reporting to the Engineering Manager 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.

Duties Performed

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

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.
• 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.

How to apply

Please ensure that you include a cover letter outlining why you have applied for this position. A paragraph or two is all we need to better understand why you are the best person for this role. Please submit your application via Seek by no later than 12 September If you have any questions, please contact Reality Check on who we have engaged to provide us a shortlist for these positions. Only applicants with the right to work in Australia will be considered. Please note that only shortlisted candidates will be contacted.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, included unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate from whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.