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KNEAT Validation Engineer
2 months ago
PSC Biotech is seeking a skilled Validation Engineer to lead and perform commissioning, qualification, and validation activities for our KNEAT validation process. As a key member of our team, you will ensure compliance with regulatory requirements and industry standards.
Key Responsibilities- Lead and execute validation activities for KNEAT, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop and execute validation protocols, ensuring compliance with regulatory requirements and industry standards.
- Work closely with cross-functional teams to ensure alignment on validation strategies and timelines.
- Communicate effectively with internal and external stakeholders to provide updates on validation activities.
- Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards in all validation activities.
- Bachelor's Degree in Engineering or related field.
- 3-5+ years of KNEAT Validation Engineering experience.
- Proven experience with the KNEAT platform is mandatory.
- Strong understanding of regulatory requirements and industry standards.
- Excellent communication and interpersonal skills.
- Detail-oriented with a strong ability to problem-solve and make data-driven decisions.
- Adaptable and flexible.
- Strong time-management and organizational skills.
- Competitive compensation and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
- Recognition and rewards for outstanding performance.
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. We are passionate about bringing the best and brightest together to form a truly special team.
