Job Title: Senior Pharmaceutical Commissioning Qualification Validation Engineer
Role Overview:
We are seeking a highly experienced and skilled Senior CQV Engineer to join our team in Melbourne, Australia.
The successful candidate will be responsible for developing comprehensive documentation to support the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
Key Responsibilities:
* Develop high-quality documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
* Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
* Planning / coordinating work and directing small teams in document development and/or execution.
Requirements:
* BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.
* 5 – 12 years' experience performing commissioning and/or qualification activities in an FDA regulated industry.
* Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
What We Offer:
* A Highly Competitive Salary Package.
* Continuing education opportunities (internal and external).
* Challenging and engaging projects in a fast-paced environment.
About Us:
Our company is a global leader in commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness to FDA regulated and other mission-critical industries.