Pharmaceutical Commissioning Qualification Validation Engineer
7 days ago
Cagents is seeking a highly skilled Pharmaceutical Commissioning Qualification Validation Engineer to join our team. As a key member of our operations, you will be responsible for developing documentation to support Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Key Responsibilities- Documentation Development: Create and maintain accurate and comprehensive documentation for Commissioning, Qualification, and Validation activities.
- Protocol Writing and Execution: Develop and execute protocols for field verification and develop summary reports at client sites.
- CQV Leadership: Provide guidance and leadership on cGMP principles and practices for the integration and delivery of CQV services for our Life Sciences clients.
- CQV Documentation Management: Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
- Onsite and Offsite Activities: Support onsite and offsite activities, including FATs, SATs, IOQ and PQ Executions, and System Walkdowns.
- CQV Planning and Direction: Plan and direct C&Q activities, ensuring timely and effective completion.
- Life Science Manufacturing Expertise: Possess expertise in life science manufacturing processes, including biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience.
- Regulatory Compliance: Familiarity with Baseline Guide 5 (Second Edition) is a plus.
- Education: Bachelor's or Master's degree in a relevant science or engineering field, or equivalent years of hands-on experience.
- Experience: 2-7 years of experience performing commissioning and/or qualification activities in an FDA-regulated industry.
- Technical Skills: Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
- Attention to Detail: High attention to detail and ability to multi-task.
- Communication Skills: Excellent oral and written communication skills, with ability to work independently and build project teams.
- Software Skills: Expertise in Microsoft Word and Excel.
- Travel and Work Requirements: Ability to travel domestically if required and work in Australia without sponsorship.
- Competitive Salary
- Continuing Education
- Cutting-Edge Projects
- Comprehensive Health Insurance
- Paid Time Off
- ESOP/401K
- Company Pension Contribution
- Company Paid Life Assurance
- Company Paid Income Protection/Long-Term Disability
- Career/Professional Development Opportunities
- Additional Benefits/Leave Entitlements
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Melbourne, Victoria, Australia CAI Full timeAbout CAICAI is a 100% employee-owned company established in 1996, with a strong presence in the pharmaceutical and life sciences industries. Our team of experts provides commissioning, qualification, and validation services to clients worldwide.Job SummaryWe are seeking a highly skilled Commissioning and Qualification Expert to join our team in Australia....
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Melbourne, Victoria, Australia CAI Full timeSenior Pharmaceutical Commissioning Qualification Validation EngineerWe are seeking a highly skilled Senior Pharmaceutical Commissioning Qualification Validation Engineer to join our team in Australia.About the RoleThe successful candidate will be responsible for developing documentation to support Commissioning, Qualification, and Validation of...
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Melbourne, Victoria, Australia Cagents Full time{"title": "Senior Pharmaceutical Commissioning Qualification Validation Engineer", "description": "About the RoleWe are seeking a highly skilled Senior Pharmaceutical Commissioning Qualification Validation Engineer to join our team in Australia. As a key member of our team, you will be responsible for developing documentation to support Commissioning,...
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Melbourne, Victoria, Australia CAI Full timeJob DescriptionCAI is seeking a highly skilled Commissioning and Qualification Engineer to join our team in Australia.About CAICAI is a 100% employee-owned company established in 1996, with a strong commitment to excellence and customer satisfaction. We provide a wide range of services related to operational readiness, including commissioning, qualification,...
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Melbourne, Victoria, Australia Cagents Full timeJob Summary:Cagents is seeking a highly skilled Pharmaceutical Commissioning Qualification Validation Specialist to join our team. As a key member of our operations, you will be responsible for developing documentation to support Commissioning, Qualifications, and Validation of pharmaceutical facilities, utilities, and equipment.Key Responsibilities:Support...
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Melbourne, Victoria, Australia Cagents Full timeJob DescriptionJob Title: Senior Pharmaceutical Commissioning Qualification Validation ExpertCompany: CagentsLocation: AustraliaJob Type: Full TimeAbout Us: Cagents is a leading provider of commissioning, qualification, and validation services to the pharmaceutical industry.Job Summary: We are seeking a highly experienced Senior Pharmaceutical Commissioning...
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