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Commissioning Qualification Validation Engineer
2 months ago
PSC Biotech is a leading provider of essential services to the life sciences industry, ensuring that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our MissionWe are passionate about bringing the best and brightest together to form a truly special team. Our goal is to provide our clients with exceptional services, enabling them to achieve success in the life sciences industry.
Your RoleWe are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Professional, you will work alongside a talented team in an exciting, developing, and diverse biotechnology landscape.
- 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.
- Additional duties as assigned.
- 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.
