Commissioning Qualification Validation Engineer
2 months ago
About PSC Biotech Corporation
PSC Biotech Corporation 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 Mission
We strive to deliver exceptional results and exceed our clients' expectations by leveraging our global expertise, cutting-edge technology, and collaborative approach.
The Role
We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' facilities, equipment, and utilities.
Key Responsibilities
- Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
- Develop and execute validation protocols, ensuring compliance with cGMP requirements, regulatory requirements, and quality standards.
- Conduct risk assessments, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Perform preventative maintenance and conduct process equipment and clean room validation.
- Establish validation standards and develop performance testing and quality control measures.
- Collaborate with multiple departments on assigned project activities and deliverables.
Requirements
- 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.
What We Offer
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive compensation and benefits package.
- A chance to work with a global team of experts in the life sciences industry.
Equal Opportunity Employment Statement
PSC Biotech Corporation is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer-sponsored activities and programs.
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Melbourne, Victoria, Australia PSC Biotech Corporation Full timeAbout the RolePSC Biotech Corporation is seeking a highly skilled Commissioning Qualification Validation Specialist to join our team. As a key member of our team, you will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.Key ResponsibilitiesCommission, qualify, and validate GxP...
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