Senior Commissioning Qualification Validation Engineer (Biotech)

TL;DR

Senior Commissioning, Qualification, and Validation (CQV) Engineer (Biotech): Ensuring systems, facilities, and equipment meet design requirements for biomedical and pharmaceutical projects with an accent on CQV protocol execution and GMP compliance. Focus on authoring controlled documents, executing FAT/SAT/IQ/OQ/PQ activities, and managing project deliverables within a 12-month contract.

Location: Melbourne, Australia (Onsite)

Company

hirify.global provides professional services and consulting to the life sciences industry, focusing on maintaining product integrity and enabling steady growth.

What you will do

• Commission, qualify, and validate facilities, utilities, and equipment for major capital projects.
• Author, review, and execute controlled documents including DQ, FAT, SAT, IQ, OQ, PQ, and PV.
• Implement safety programs and coordinate risk analyses and design reviews.
• Write and maintain GMP and GDP documentation and technical specifications.
• Collaborate with cross-functional departments and manage relationships with contractors and vendors.
• Lead and simplify CQV functions, reports, and internal processes.

Requirements

• Bachelor’s Degree in Engineering or Life Science.
• 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
• Proficiency in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Strong understanding of cGMPs and CFR21 Part 11 guidelines.
• Proven experience in developing SOPs, validation policies, and CQV protocols.
• Excellent communication and organizational skills for managing multi-task project environments.