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Commissioning Qualification Validation Specialist
2 months ago
PSC 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.
Job SummaryWe are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Engineer, you will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
Key Responsibilities- Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
- Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
- Draft and execute validation documentation such as: Validation Project & Master Plans, Requirement Specifications (URS, DS, FS), IQ and OQ Test Scripts, IQ/OQ/PQ Protocols, Validation Summary Report.
- Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Conduct preventative maintenance and perform risk assessments.
- Recommended process improvements where needed ensuring compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Execute process equipment and clean room validation.
- Clearly communicate all progress, updates, and action steps for assigned projects. 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 is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive compensation and benefits package, as well as opportunities for professional growth and development.
