Senior Pharmaceutical Commissioning Qualification Validation Engineer

vor 4 Wochen


Melbourne, Österreich Cagents Vollzeit
Senior Pharmaceutical Commissioning Qualification Validation Engineer - Australia

Melbourne / 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 StandardOur 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 integrityWe serve each otherWe serve societyWe 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 experience5 – 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 cGMP 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 issuesHigh attention to detailAbility to multi-task and take initiative to accomplish assigned tasks accurately by established deadlinesAbility to work independently, while quickly building and nurturing a project teamManaging 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 WalkdownsExperience in planning / directing C&Q activitiesProficient 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 ExcelExcellent oral and written English are required.Able to travel domestically if requiredAble to work in Australia without sponsorshipIn return for your skills and knowledge, CAI offers a wide range of benefits including:Highly Competitive SalaryContinuing 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 CountryMedical / Dental / Vision (In accordance with each countries’ applicable regulations)Professional Development (Approximately $5,000 paid career-related, continuing education)ESOP/401k – 15% Company ContributionCompany Paid Long-Term DisabilityCompany Paid Life InsuranceCompany Paid Parental Leave (In accordance with each countries’ applicable regulations)

#J-18808-Ljbffr

  • Melbourne, Österreich Cagents Vollzeit

    Senior Pharmaceutical Commissioning Qualification Validation Engineer - Australia Melbourne / 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...


  • Melbourne, Österreich CAI Vollzeit

    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% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide....


  • Melbourne, Österreich CAI Vollzeit

    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% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide....


  • Melbourne, Österreich CAI Vollzeit

    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% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide....


  • Melbourne, Österreich PSC Biotech Corporation Vollzeit

    Job DescriptionPSC 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, and you can be a part of our team’s achievements. Employing a...


  • Melbourne, Österreich PSC Biotech Corporation Vollzeit

    Job 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 clients’ success, and you can be a part of our team’s achievements. Employing a...


  • Melbourne, Österreich CAI Vollzeit

    About CAI:CAI was established in 1996, it has grown year over year to more than 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated, Data Centers and other mission critical industries.Meeting a Higher StandardOur approach is simple;...


  • Melbourne, Österreich Amazon Vollzeit

    Job ID: 2681191 | Amazon Corporate Services Pty LtdAWS 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 running. We support all AWS data centers and all of the servers, storage, networking, power, and cooling equipment that ensure our customers...


  • Melbourne, Österreich Amazon Vollzeit

    Job ID: 2681191 | Amazon Corporate Services Pty LtdAWS 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 running. We support all AWS data centers and all of the servers, storage, networking, power, and cooling equipment that ensure our customers...


  • Melbourne, Österreich Cagents Vollzeit

    CAI was established in 1996, it has grown year over year to more than 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated, Data Centers and other mission critical industries. Meeting a Higher Standard Our approach is simple; we put...


  • Melbourne, Österreich CAI Vollzeit

    About CAI:CAI was established in 1996, it has grown year over year to more than 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated, Data Centers and other mission critical industries.Meeting a Higher StandardOur approach is simple;...


  • Melbourne, Österreich Astute People Vollzeit

    Astute's Renewables team is proudly partnering with a leading EPC company in the utility-scale Solar and BESS market, that are committed to professional development and sustainability. Together we are looking for a Senior Electrical Engineer to join their growing design team and participate in a growing pipeline of solar and BESS projects.The Senior...


  • Melbourne, Österreich CAI Vollzeit

    About CAI:CAI was established in 1996, it has grown year over year to more than 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated, Data Centers and other mission critical industries.Meeting a Higher StandardOur approach is simple;...


  • Melbourne, Österreich Astute People Vollzeit

    Astute's Power team is partnering with a Principal Contractor on an Energy from Waste project to recruit a Lead Commissioning Engineer on a 12-month minimum contract for its Leeds site.The Lead Commissioning Engineer role comes with a day rate of 550 per day.Key skillsDemonstrate leadership and commitment to HSEQ. Actively encouraging and leading the...

  • Protection and Control

    vor 4 Wochen


    Melbourne, Österreich First Recruitment Group Vollzeit

    Our client is looking to recruit a Protection and Control Commissioning Engineer for a 6 month contract.Protection and Control (P&C) Commissioning EngineerFlexible but preferably Birmingham or Glasgow6 Month ContractBPSSInside IR35Job Description:You will be working within our Power Networks team as a P&C commissioning engineer to oversee the installation...

  • Commissioning Engineer

    vor 4 Wochen


    Melbourne, Österreich SecureEnergy JV Vollzeit

    Electrical/Electronic Engineering (Engineering) Bring your perspective to one of Australia’s largest energy projects! Elecnor has been contracted to build EnergyConnect, a new 700km transmission line extending from Wagga Wagga NSW to the South Australian border. This backbone infrastructure will connect customers with more renewable energy enabling...


  • Melbourne, Österreich Randstad Vollzeit

    Position Overview: Seeking a flexible and experienced Senior Electrical Engineer to join a well-established Engineering consultancy here in Melbourne. The ideal candidate will have a strong background in electrical engineering, with experience in business development and commissioning within the building services sector. Key Responsibilities: Lead...


  • Melbourne, Österreich Goodhue Senior Living Vollzeit

    Senior Software Engineer - Network Metadata Modelling Microsoft Corporation - Melbourne, VICIT Source: uWorkin JOB DESCRIPTION Do you love to work on the latest technologies? Do you want to work at the forefront of Cloud Computing to design, grow and evolve the Azure Network stack, supporting customers from the smallest server-less app to the largest AI...

  • Electrical Testing

    vor 4 Wochen


    Melbourne, Österreich C2ogroup Vollzeit

    Electrical Testing & Commissioning Engineer Posted on 01 November, 2022We are currently seeking motivated and qualified trades personnel with good communication and interpersonal skills, for work on Major Projects within the infrastructure, mining and energy sectors in the following occupation:Electrical Testing & Commissioning Engineer – Primary &...


  • City of Melbourne, Österreich Astute People Vollzeit

    Astute's Power team is partnering with a Principal Contractor on an Energy from Waste project to recruit a Lead Commissioning Engineer on a 12-month minimum contract for its Leeds site. The Lead Commissioning Engineer role comes with a day rate of 550 per day.Key skills Demonstrate leadership and commitment to HSEQ. Actively encouraging and leading the...