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Senior CQV Specialist
2 weeks ago
CQV Professional Wanted for Exciting Biotechnology Projects
We are looking for a skilled Commissioning, Qualification, and Validation (CQV) engineer to join our talented team in a developing biotechnology landscape. The successful candidate will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
- Key Responsibilities:
- Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
- Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
- Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Conduct preventative maintenance and perform risk assessments.
- Recommend 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.
- 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.
- Must have strong written and verbal communication skills.
PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We strive to create an inclusive and diverse work environment that promotes professional growth and development.
