Commissioning, Qualification and Validation

10 hours ago

Melbourne, Australia PQE Australia Pty Ltd Full time

**About the business and the role**

Are you ready to join a **world leader** in the exciting and dynamic fields of the **Pharmaceutical and Medical Device industries**? **PQE Group**has been at the forefront of these industries **since 1998**, with **40 subsidiaries** and more than **2000 employees in Europe, Asia and the Americas**.

Due to a constant growth, PQE is looking for a **Commissioning, Qualification and Validation (CQV) Consultant** based in **Melbourne, Australia.**

**Core responsibilities**:

- Lead and deliver the project objectives, controlling scope changes to meet budget and schedule, functionality according to the URSs, Equipment TRSs, GMP, safety and environmental requirements during all phases of the project (Design, Procurement, and Quality Assurance)
- Ensure compliance with Current Good Manufacturing Practice as applicable to this role and customer global and local quality policies.
- Ensure the Quality Assurance of the lifecycle documentation produced.
- Ensure that project tasks are managed in a way that creates a safe, healthy and secure workplace for the staff and contractors involved in implementing projects and for those using the facilities created or modified by these projects.
- Ensure that project tasks are managed in a way that recognizes GMP and the need to actively manage the risk of non-compliance.
- Assist in planning and co-ordination of any plant shutdown activities.
- Assist in or manage as directed, the development of operational and maintenance manuals and training materials.
- Complete project tasks from start to finish, so that they are completed to scope, within budget and on time while achieving zero harm, identified returns and meeting cash flow requirements.
- Broad experience in HVAC and Cleanrooms Commissioning and Qualification activities i.e. URS, Design aspects, DQ, FAT, SAT, IQ, OQ and PQ documentation.
- Preparation of Quality Risk Assessment, Drafting/reviewing of QMS SOPs, Quality Risk Management, Complaints, deviations and CAPAs management, Change Control management

**Skills Required**:

- At least a Bachelors Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
- At least 3 years of relevant work experience;
- An underlying process and engineering systems/services experience gained in the GxP industry
- Good knowledge of cGMP guidelines and Data integrity principles
- English Fluent (mandatory)
- Full availability to travel domestically and abroad

**Salary**: $70,000.00 - $80,000.00 per year

Schedule:

- 8 hour shift
- Monday to Friday

Supplemental pay types:

- Performance bonus

**Language**:

- English (required)

Work Authorisation:

- Australia (required)

Work Location: In person

  • Pharmaceutical Commissioning Qualification Validation Engineer

    1 week ago

    Melbourne, Victoria, Australia CAI Full time $73,150 - $115,000 per year

    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 700...

  • Pharmaceutical Commissioning Qualification Validation Engineer

    2 weeks ago

    Melbourne, Victoria, Australia CAI Full time $80,000 - $120,000 per year

    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 700 people...

  • Pharmaceutical Commissioning Qualification Validation Engineer

    2 weeks ago

    Melbourne, Victoria, Australia CAI Full time US$73,150 - US$115,000 per year

    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 CAICAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people...

  • Senior Pharmaceutical Commissioning Qualification Validation Engineer

    1 week ago

    Melbourne, Victoria, Australia CAI Full time $120,000 - $180,000 per year

    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 700...

  • Validation Specialist

    6 days ago

    Melbourne, Australia Bell People Consultants Full time

    Global 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

    4 days ago

    Melbourne, Victoria, Australia myGwork - LGBTQ+ Business Community Full time $80,000 - $120,000 per year

    This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.DescriptionAWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud...

  • Commissioning Coordinator

    1 week 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...

  • Commissions Team Leader

    1 week ago

    Melbourne, Australia Ray White and Loan Market Full time

    **Who are we?** Loan Market Group is the largest and fastest-growing mortgage brokerage aggregator in Australasia. Proudly family-owned and led, it was founded in 1994 by Sam White and is part of the White Family Group of companies comprising Loan Market, PLAN Australia, Choice Aggregation Services, FAST, Home Now and Ray White. There are 8,000+ mortgage...

  • Commissions Officer

    2 weeks ago

    Melbourne, Australia Ray White and Loan Market Full time

    Loan Market Group is the largest and fastest-growing mortgage brokerage aggregator in Australasia. Proudly family-owned and led, it was founded in 1994 by Sam White and is part of the White Family Group of companies comprising Loan Market, PLAN Australia, Choice Aggregation Services, FAST, Home Now and Ray White. There are 8,000+ mortgage brokers that makeup...

  • Head of Testing

    2 weeks ago

    Melbourne, Australia Siemens Full time

    Are you a highly talented Testing & Commissioning leader with experience in Rail systems? **Siemens Mobility** is an outstanding place to have a career in an innovative environment. Siemens Mobility Rail Infrastructure business supplies the global markets of rail and road-bound transport with innovative products and solutions for Rail Automation, Rail...