-
Senior Verification and Validation Engineer
3 days ago
Brooks Automation Brisbane, Australia Full timeDescription · Brooks is a growing, fast-paced technology leader of automation solutions which support the dynamic and expanding semiconductor and life sciences lab markets. At Brooks, new ideas, technologies, and ways of thinking are driving our future. Our customer-focused cult ...
-
Psc Biotech Corporation Brisbane, Australia Full timeJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our cl ...
-
Brooks Automation, Inc. Brisbane, Australia Full timeBrooks is a growing, fast-paced technology leader of automation solutions which support the dynamic and expanding semiconductor and life sciences lab markets. · At Brooks, new ideas, technologies, and ways of thinking are driving our future. · Our customer-focused culture encoura ...
-
Validation Engineer- Infection Control, QLD
4 days ago
Getinge Brisbane, Australia Full timeGetinge are seeking applications from any suitably qualified employees that may be looking to move into the position of Validation Engineer – Infection Control, Queensland. This role reports to the Validation Manager, Australia, and is based out of the Brisbane office. · As the ...
-
Cagents Brisbane, Australia Full timeSenior Pharmaceutical Commissioning Qualification Validation Engineer - AustraliaBrisbane, Australia / Australia / Full TimeCAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experi ...
-
Cagents Brisbane, Australia Full timeSenior Pharmaceutical Commissioning Qualification Validation Engineer - Australia Brisbane, Australia / Australia / Full Time CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Expe ...
-
Plant Engineering Manager
1 day ago
Thermo Fisher Scientific Brisbane, Australia**Position Summary**: · Works in a multidisciplinary team for tracking equipment life cycle process on site to ensure that all critical process equipment/systems remain continuously ready for safe, effective, efficient, and compliant operations · Working with the CAPEX engineerin ...
-
Trades Assistants
1 week ago
Melbourne Recruitment Services Pty Ltd Brisbane, AustraliaWeekly pay, quality rates, workshop & site-based works · - Short Term, Long Term + Temporary to Permanant Assignments · - A wide variety of available opportunities for immediate starts · Querec Trades and Labour Hire is regarded as an employer of choice for quality, versatile, re ...
-
A05 Project Support Officer
1 week ago
AWX Executive Brisbane, AustraliaLocation: Brisbane City · - Pay rate: $59-64/hr (Depending on experience) · - Contract Duration: Until September 2024 · AWX Executive is looking for a Project Support Officer for one of our government clients. · - Location: Brisbane City · - Pay rate: $59-64/hr (Depending on expe ...
-
15794i A05 Project Support Officer
1 week ago
Top Office Group Brisbane Central Business District, AustraliaWe are seeking a highly organised and detail orientated data administrator for a temporary assignment with a government department located in the Brisbane CBD. · Working as part of state-wide project team you will be responsible for managing the lifecycle of engineering drawing i ...
-
Qc Team Leader, Chemistry
4 days ago
Thermo Fisher Scientific Brisbane, AustraliaPosition Summary: The Quality Control Laboratory is responsible for the execution of Qualification/Validation Protocols. Technical Transfer (as applicable) and Performance for Quality Control tests undertaken within the Quality Control Laboratory. · The QC Team Leader of Chemistr ...
-
Boeing RIV Site Brisbane, AustraliaAbout us · As one of the country's leading and preferred defence partners, Boeing Defence Australia (BDA) develops and sustains leading edge technologies for some of Australia's largest and most complex defence projects. · Recently identified as one of the top 20 places to work i ...
-
Client Experience
1 week ago
Solera Brisbane, AustraliaJob Title: Client Experience, Supply Chain, and Quality Specialist · About the Role: · We are seeking an experienced Supply Chain and Client Experience lead, focusing on the Quality and the Supply Chain related functions. The focus will be on services provided to our key insurer ...
-
Experienced Boilermaker Needed Immediately
1 week ago
Engineering Trades Australia Brisbane, AustraliaGreat rates and plenty of OT work available · - Immediate start · - Full-time opportunity after 3 months · Engineering Trades Australia are currently partnered with a specialist manufacturer West of Brisbane who provide innovative engineering solutions and are looking for an expe ...
-
Boilermaker Opportunity
2 days ago
Engineering Trades Australia Brisbane, Australia$45 p/h + Penalty Rates · - Start date from 27/02/2023 · - Clean working environment with state of the art equipment · Engineering Trades Australia are currently partnered with a Engineering and a Heavy Steel Fabrication workshop looking for up to two Boilermakers to join their w ...
-
Validation Specialist
6 days ago
PSC Biotech Brisbane, AustraliaPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our clients' success, an ...
-
Validation Manager
1 week ago
Symbion Brisbane, Australia**- **Job no**:493900** · ***: · - **Business unit**: DoseAid Pty Ltd, ABN ** · ***: · - **Position location**: Mansfield** · ***: · - **Work type**:Full Time Permanent** · ***: · - **Location**:QLD - Brisbane****: · **Validation Manager - DoseAid, Brisbane QLD** · **About us**: ...
-
Boilermaker
1 week ago
Engineering Trades Australia Brisbane, Australia$57ph - $71ph + Penalties · - Day & Night shifts available · - Back-to-back Shutdowns until the end of the year · Engineering Trades Australia is a progressive Australian Labour Hire organisation, that specialises purely in the Fabrication & Engineering Industry. · **We are curre ...
-
QA Officer
1 week ago
Thermo Fisher Scientific Brisbane, AustraliaAt Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. · **Position Summary**: · The Brisbane site is a multi-product ...
-
BOEING Brisbane, AustraliaAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate ...
Senior Pharmaceutical Commissioning Qualification Validation Engineer - Brisbane City, Australia - Cagents
Description
Senior Pharmaceutical Commissioning Qualification Validation Engineer - Australia Brisbane, Australia / Australia / Full Time 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 worldwide.
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: We act with integrity We serve each other We serve society We work for our future.
With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals.We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude.
That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space.
You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies.
As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training.
Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.Requirements include:
Position Description:
We are now seeking a Senior CQV Engineer to join our growing operations in Australia.
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation.
These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a Senior CQV Engineer in CAI is to: Develop 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.Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
Position 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.
Ideally, you will already have 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.
Provide c GMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues High attention to detail Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines Ability to work independently, while quickly building and nurturing a project team Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns Experience in planning / directing C&Q activities Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Familiarity with Baseline Guide 5 (Second Edition) a plusOther Requirements:
Expertise in Microsoft Word and Excel Excellent oral and written English are required.
Able to travel domestically if required Able to work in Australia without sponsorship In return for your skills and knowledge, CAI offers a wide range of benefits including: Highly Competitive Salary Continuing education (internal and external) Opportunities to work on cutting edge projects in a highly evolving field (Varies by Country, Below is a General Overview)100% Employee Owned24 Days PTO/5 Sick days per year + Additional Holidays depending on Country Medical / Dental / Vision (In accordance with each countries' applicable regulations)Professional Development (Approximately $5,000 paid career-related, continuing education)ESOP/401k – 15% Company Contribution Company Paid Long-Term Disability Company Paid Life Insurance Company Paid Parental Leave (In accordance with each countries' applicable regulations)
#J-18808-Ljbffr