CQV Engineer

Overview

We are seeking a dedicated and detail-oriented Commissioning, Qualification, and Validation (CQV) Engineer to join our dynamic team. The ideal candidate will have expertise in iopq qualification and temperature mapping, ensuring that our equipment and processes meet regulatory standards and operate reliably. We embrace diversity and are committed to fostering an inclusive environment where every team member can thrive and contribute their unique perspectives.

Responsibilities

• Develop, review, and execute Installation, Operational, and Performance Qualification (IOPQ) protocols.
• Conduct temperature mapping studies to validate controlled environments and equipment performance.
• Collaborate with cross-functional teams to ensure compliance with industry regulations and standards.
• Analyze data and prepare comprehensive reports documenting qualification and validation activities.
• Identify opportunities for continuous improvement in CQV processes and implement best practices.
• Support troubleshooting activities related to equipment and process validation.
• Maintain accurate and up-to-date documentation in accordance with company policies and regulatory requirements.

Qualifications

• Proven experience in CQV engineering, specifically with IOPQ qualification and temperature mapping.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, GMP) and industry standards.
• Excellent analytical skills and attention to detail.
• Ability to work effectively both independently and within diverse team settings.
• Strong communication skills, with the ability to document and present technical information clearly.
• Commitment to uphold principles of diversity, equity, and inclusion in all professional interactions.

Day-to-Day

• Plan and execute qualification protocols in compliance with regulatory guidelines.
• Perform temperature mapping and analyze environmental data for equipment and facilities.
• Engage with multidisciplinary teams to ensure alignment on project goals and timelines.
• Prepare detailed reports and maintain validation documentation.
• Participate in continuous learning and training initiatives to stay abreast of CQV industry advancements.
• Foster an inclusive team culture by valuing diverse viewpoints and facilitating open communication.

CMC is an equal opportunity employer. We welcome applications from individuals of all ages and backgrounds and assess candidates solely on merit, skills, and potential. No terminology in this advert is intended to discriminate in any way.

We welcome applications/enquiries from individuals of all backgrounds and are committed to providing equal access to employment opportunities across all regions in which we operate.