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Adelaide, South Australia PSC Biotech Full timeJob Title: Commissioning Qualification Validation EngineerAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. Our global team of experts spans across strategically located offices, and we...
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Adelaide, South Australia PSC Biotech Full timeJob Title: Commissioning Qualification Validation EngineerAbout the RolePSC Biotech is a leading provider of life sciences services, ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. We are seeking a highly skilled Commissioning Qualification Validation Engineer to join our...
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Commissioning Qualification Validation Specialist
2 months ago
PSC Biotech is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team in the life sciences industry. As a CQV Professional, you will work closely with our talented team to deliver high-quality projects that meet the highest standards of regulatory compliance.
Key Responsibilities- Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
- Develop and execute validation protocols, including IQ and OQ test scripts, validation project and master plans, and validation summary reports.
- Conduct risk assessments, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Perform preventative maintenance and risk assessments, and recommend process improvements to ensure compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
- 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
- Sound industry knowledge, project proficiency, and autonomy expected.
- Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
- Understands current risk-based validation approaches.
- Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
- Experience with system impact assessment and risk assessment.
- Good knowledge of the code of GMP and PIC/S code.
- Previous experience in the Life Sciences Industry is required.
- Previous experience in GxP Industries are required.
- Must be adaptable, customer service oriented, have a positive attitude.
- Excellent organizational skills.
- High attention to detail.
- Must have strong written and verbal communication skills.
PSC Biotech offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to providing our employees with the tools and resources they need to succeed in their roles.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced CQV Professional looking for a new challenge, please submit your application.