Lead Validation Engineer in Pharmaceutical Commissioning

2 weeks ago


Brisbane, California, United States CAI Full time
Position Overview:
As a Lead Validation Engineer specializing in Pharmaceutical Commissioning, you will play a crucial role in our operations. Your expertise will be essential in ensuring that our systems and processes meet the highest standards of quality and compliance.

About CAI:

CAI is a fully employee-owned organization that has been a leader in the industry since its inception. With a commitment to operational excellence, we provide a range of services including commissioning, qualification, validation, and project management to clients in FDA-regulated sectors.

Our core values emphasize integrity, teamwork, and a commitment to societal benefit. We believe that the success of our employees directly contributes to the success of our clients and the community.


Key Responsibilities:
As a Lead Validation Engineer, your primary responsibilities will include:
  • Developing comprehensive documentation for the commissioning, qualification, and validation of pharmaceutical facilities and equipment.
  • Executing protocols and conducting field verification to ensure compliance with industry standards.
  • Leading small teams in the development and execution of validation documents.
  • Providing guidance and support for the integration of CQV services for our life sciences clients.

Qualifications:
To be successful in this role, you should possess:
  • A Bachelor’s or Master’s degree in a relevant scientific or engineering discipline, or equivalent hands-on experience.
  • 5 to 12 years of experience in commissioning and qualification activities within an FDA-regulated environment.
  • Strong problem-solving skills and attention to detail.
  • The ability to manage multiple tasks and meet deadlines effectively.
  • Proficiency in life science manufacturing processes, including biotech and aseptic processing.

Additional Requirements:
We are looking for candidates who are:
  • Proficient in Microsoft Office applications.
  • Fluent in English, both written and spoken.
  • Able to travel as necessary.
  • Eligible to work in Australia without sponsorship.

Benefits:
CAI offers a competitive salary and a comprehensive benefits package, including opportunities for continuing education and professional development. Join us in making a difference in the life sciences sector.

  • Brisbane, California, United States Ultragenyx Pharmaceutical Full time

    Job SummaryThe Senior Scientist, Analytical Development will lead the analytical development activities of Ultragenyx pipeline projects, including monoclonal antibodies, proteins, and other therapeutic modalities.Key ResponsibilitiesDevelop and qualify physical chemical analytical methods for in-process, drug substance and drug product characterization,...


  • Brisbane, California, United States AMPLE. LLC Full time

    About Ample, Inc.Ample, Inc. is at the forefront of the electric vehicle industry, innovating a revolutionary method for energy delivery to electric vehicles. We harness cutting-edge robotics to facilitate modular battery swapping, providing a service that is as swift, economical, and user-friendly as traditional refueling.Position Overview:As a Senior...


  • Brisbane, California, United States Ample, Inc. Full time

    Job OverviewAre you passionate about revolutionizing the energy sector? Ample, Inc. stands at the forefront of electric vehicle innovation, creating groundbreaking solutions for energy delivery to electric vehicles. Our advanced robotics facilitate modular battery swapping, making it as efficient and accessible as traditional refueling methods. We are a...


  • Brisbane, California, United States AMPLE. LLC Full time

    Position Overview:Are you ready to make a significant impact in the electric vehicle industry? Ample, Inc. is at the forefront of innovation, developing groundbreaking solutions for energy delivery to electric vehicles.About Us:At Ample, we leverage cutting-edge robotics to facilitate modular battery swapping, offering a solution that is as quick,...


  • Brisbane, California, United States Ultragenyx Full time

    About the RoleAt Ultragenyx, we are seeking a highly skilled Senior Scientist to lead our analytical development and characterization activities. As a key member of our team, you will be responsible for developing and qualifying physical-chemical analytical methods for in-process, drug substance, and drug product characterization, release, and stability...


  • Brisbane, California, United States Entegee Full time

    About Entegee Entegee is renowned for its pioneering work in custom automation projects. Our organization has established itself as a leading player globally within the realm of controls solutions. By joining Entegee's team,You Will Be Empowered To Unlock Your Full Potential As A Top Performing Controls Engineer. About The Role: EHS Manager Position At...


  • Brisbane, California, United States Bristol-Myers Squibb Full time

    About the RoleBristol Myers Squibb is seeking a highly motivated scientist to join our Quantitative Systems Pharmacology (QSP) team in the Immunology disease area. As a Senior Quantitative Systems Pharmacology Investigator or Quantitative Systems Pharmacology Investigator, you will play a critical role in developing and applying QSP models to address...


  • Brisbane, California, United States Bristol-Myers Squibb Full time

    Job SummaryBristol-Myers Squibb is a leading biopharmaceutical company that is transforming patients' lives through science. We are seeking a highly motivated and experienced Senior Biotherapeutics Scientist to join our Discovery Biotherapeutics team.About the RoleLead and carry out laboratory experiments related to antibody-drug conjugation, purification,...


  • Brisbane, California, United States Rheinmetall Full time

    About the TeamThe Electronics Engineering division is dedicated to the design, integration, and evaluation of both commercial and defense electrical/electronic systems.About the RoleThe Electrical/Electronics Engineer, working under general guidance, is tasked with assisting in the development, integration, and assessment of commercial off-the-shelf (COTS),...


  • Brisbane, California, United States Mammoth Biosciences Full time

    POSITION SUMMARYMammoth Biosciences is seeking a Senior Program Manager to oversee our expanding CRISPR-based Therapeutics initiatives as we advance them towards commercialization. The Senior Program Manager will be tasked with the strategic planning, supervision, and execution of projects from Gene Editing Technology Development through Therapeutics Drug...


  • Brisbane, California, United States CareDx, Inc. Full time

    Position OverviewLead Cybersecurity ArchitectCareDx, Inc. is at the forefront of precision medicine, dedicated to enhancing the lives of transplant patients through innovative healthcare solutions. Our organization specializes in the development and delivery of unique products, testing services, and digital health solutions that support patients and...


  • Brisbane, California, United States Gate Bioscience, Inc. Full time

    Job DescriptionGate Bioscience, Inc. is a pioneering biotech company dedicated to revolutionizing the field of medicine with its innovative Molecular Gates technology. Our mission is to develop a new class of medicines that selectively eliminate harmful extracellular proteins, thereby curing diseases at their origin.The Role:We are seeking an exceptional...


  • Brisbane, California, United States CareDx, Inc. Full time

    Job DescriptionAbout CareDx, Inc.CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. Our company offers products, testing services, and digital healthcare solutions along the pre- and...


  • Brisbane, California, United States Heirloom Carbon Full time

    About Us Across the globe, from the serene waters of Turkey and Oman to the stunning terraces of Yellowstone, our planet naturally captures carbon dioxide from the atmosphere and transforms it into stone. For ages, Earth has depended on this process to maintain its carbon balance. What if we could harness this ability? What if we could accelerate it, scale...


  • Brisbane, California, United States Mammoth Biosciences Full time

    Mammoth Biosciences OPPORTUNITY Mammoth is seeking a Vice President of Regulatory Strategy, Therapeutics, to spearhead the regulatory initiatives of our expanding CRISPR-based therapeutic portfolio as we transition from innovative concepts to market-ready solutions. This pivotal role will entail overseeing all facets of regulatory strategy, engagement, and...

  • IT Support Engineer

    3 weeks ago


    Brisbane, California, United States Cutera Full time

    Company DescriptionCutera, Inc. (NASDAQ: CUTR) is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right person to help grow our business.The Company's technology enables physicians to provide advanced solutions for a...


  • Brisbane, California, United States Vera Therapeutics Full time

    Job DescriptionJob Summary:The Executive Director of Health Economics and Outcomes Research will lead the development and execution of health economics and outcomes research strategies to support the commercialization of Vera Therapeutics' products. This role will be responsible for generating real-world evidence and health economics comparative...


  • Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics is seeking an experienced Executive Director to lead our Health Economics and Outcomes Research (HEOR) efforts. As a key member of our Medical Affairs and Clinical Research team, you will be responsible for generating real-world evidence and health economics comparative effectiveness research to support our product development...


  • Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics, a leading biotechnology company, is seeking a highly skilled Executive Director, Health Economics Strategist to join our team. As a key member of our organization, you will play a crucial role in advancing our mission to develop innovative treatments for serious immunological diseases.Key ResponsibilitiesDevelop and execute...


  • Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics is seeking an experienced Executive Director to lead our Health Economics and Outcomes Research (HEOR) efforts. As a key member of our Medical Affairs and Clinical Research team, you will be responsible for generating real-world evidence and health economics comparative effectiveness research to support our product development...