Commissioning Qualification Validation Engineer
vor 4 Wochen
PSC Biotech provides essential services to the life sciences industry to ensure the development, manufacturing, and distribution of healthcare products at the highest standards and in compliance with regulatory requirements. Our global team of skilled professionals across North America, Europe, Asia-Pacific, and the Middle East is dedicated to achieving our clients' success.
The Experience
At PSC Biotech, we are passionate about bringing together a diverse and multi-cultural team to create something special. Joining our team means being inspired in your career, exploring your passions, and working alongside individuals who will value and nurture your talents. We prioritize coaching and developing the next generation of industry leaders, offering not only competitive compensation and benefits but also tools for growth and learning. Your career and future are important to us.
Your Role
We are seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our dynamic team. The role involves working on GxP facilities, equipment, and utilities in various projects. Responsibilities include protocol writing and execution, risk analyses, design reviews, and ensuring compliance with industry standards. Additional duties may be assigned as needed.
Requirements
- Bachelor's Degree in a relevant science or engineering field, or equivalent hands-on experience.
- 3+ years’ experience in biotechnology and pharmaceutical industries with at least 2 years in CQV activities within a GMP environment.
- Sound industry knowledge, project proficiency, and autonomy expected.
- Experience in CQV of facility/utility/equipment, including PW, HVAC, and process or laboratory equipment.
- Understanding of current risk-based validation approaches.
- Strong written and verbal communication skills, attention to detail, and organizational abilities.
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