Senior Commissioning Qualification Validation Engineer
2 weeks ago
Senior Commissioning Qualification Validation Engineer
Melbourne, Australia | Posted on 08/12/2025
The Senior Commissioning, Qualification, and Validation (CQV) Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”
- Act as a lead and simplify CQV functions, reports, and processes.
- Support implementing safety programs for major capital projects.
- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Initiate, author, revise, review, and complete controlled documents for CQV projects.
- Review and qualify equipment for commissioning, qualification, and validation activities.
- Write and review GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
- Contact and work with contractors and vendors on assigned projects.
- Ability to travel as needed.
- Additional duties and responsibilities may be assigned from time-to-time.
Requirements
- Bachelor’s Degree in Engineering or Life Science.
- 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPs, final reports, and validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Good understanding and compliance with cGMPs and CFR21 Part 11 guidelines.
- Demonstrated strategic thinking and implementation skills; proven analytical skills with the ability to translate data into actionable plans; ability to develop and implement marketing and product/service strategies by converting them into tactical marketing plans; execute and deliver results.
- Excellent presentation and communication skills, both written and oral, for a variety of audiences.
- Highly organized in planning and time management, with the ability to multi-task.
#J-18808-Ljbffr
-
Melbourne, Victoria, Australia CAI Full time US$73,150 - US$115,000 per yearCAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.About CAICAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people...
-
City of Melbourne, Australia CAI Full timeOverview CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required. About CAI CAI is a 100% employee-owned company established in 1996, with nearly 700 people worldwide. We...
-
Melbourne, Australia Cagents Full timePharmaceutical Commissioning Qualification Validation Engineer Melbourne/Australia/Full Time CAI is looking for individuals with arangeof experiencein the areas of commissioning, qualification, and validation to join ourteam in Australia.Experience in the pharmaceutical, medical deviceor biotechnologyindustries is required. About CAI: CAI is a 100%...
-
City of Melbourne, Australia CAI Full timeOverview CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device, or biotechnology industries is required. About CAI CAI is a 100% employee-owned company established in 1996. It has grown year over year to nearly...
-
Validation Specialist
4 days ago
Melbourne, Australia Bell People Consultants Full timeGlobal Pharmaceutical Manufacturing Organisation - Excellent Contract Opportunity - Start ASAP - Melbourne Metropolitan Area **About the Organisation** Operating as a global Multinational pharmaceutical manufacturer, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace. Due to ongoing project work, our...
-
Commissioning Engineer
2 weeks ago
City of Melbourne, Australia Fashion Institute of Design & Merchandising Full timeCommissioning Engineer - Electrical - ( 184650 ) About us At HDR, we specialise in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We create an unshakable foundation for...
-
Mechanical Commissioning Engineer
2 weeks ago
Melbourne, Victoria, Australia CAI Full time $80,000 - $120,000 per yearCAI OverviewAre You Ready?CAI is a professional services company established in 1996 that has grown year over year to nearly 750 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest...
-
Commissioning Coordinator
6 days ago
Melbourne, Australia Kapitol Full time**_Ready to build a better future with us? _** At Kapitol Group, we pride ourselves on being Victoria's second largest privately owned construction company. Our vision is to continuously improve the construction industry by setting new standards for quality, safety, culture and work-life balance. We’re a team of high performing professionals obsessed...
-
Commissioning Engineer Staff
2 weeks ago
Melbourne, Victoria, Australia M.C. Dean, Inc Full time $90,000 - $120,000 per yearOverview About M.C. Dean M.C. Dean is Building Intelligence. We design, build, operate, and maintain cyber-physical solutions for the nation's most mission-critical facilities, secure environments, complex infrastructure, and global enterprises. With over 7,000 employees, our capabilities span electrical, electronic security, telecommunications, life...
-
Testing & Commissioning Engineer
2 weeks ago
Melbourne, Victoria, Australia FemEdge Solutions Full time $90,000 - $120,000 per yearIf you're a hands-on commissioning engineer passionate about HV substations and renewable energy, and want to play a key role in Australia's energy transition, look no further. We're looking for multiple engineers.About The CompanyOur client is a niche engineering consultancy providing end-to-end grid connection solutions. They specialise in HV asset...
