CQV Engineer

Overview

We are seeking a motivated and detail-oriented CQV (Commissioning, Qualification, and Validation) Engineer to join our dynamic team. The ideal candidate will have experience with validation processes and a strong interest in junior manufacturing equipment, preferably in fill-finish operations. We are committed to fostering a diverse, inclusive, and equitable workplace where all employees can thrive and contribute their unique perspectives.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, with a focus on fill-finish processes.
• Assist in commissioning activities for new and existing equipment to ensure compliance with cGMP and industry standards.
• Collaborate with cross-functional teams including manufacturing, quality assurance, and engineering to ensure successful equipment qualification.
• Document all validation activities accurately and maintain compliance with regulatory requirements.
• Support continuous improvement initiatives related to equipment qualification and process validation.
• Participate in troubleshooting and resolving equipment-related issues.
• Ensure health and safety standards are upheld in all validation activities.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Chemistry, or a related field.
• Prior experience or internships in validation of manufacturing equipment preferred; junior level positions encouraged to apply.
• Basic understanding of fill-finish manufacturing processes is highly desirable.
• Familiarity with cGMP regulations and validation documentation requirements.
• Strong analytical, problem-solving, and communication skills.
• Ability to work collaboratively in diverse teams with a commitment to inclusion and equity.
• Detail-oriented with strong organizational skills.
• Willingness to learn and develop professionally.

Day-to-Day

• Review and interpret validation protocols and specifications.
• Conduct commissioning and qualification tests on manufacturing equipment.
• Record test results and prepare validation reports.
• Liaise with operations teams to schedule validation activities minimizing downtime.
• Attend team meetings and provide updates on validation progress.
• Participate in training sessions to enhance knowledge of validation and manufacturing processes.
• Contribute ideas and feedback in a respectful and inclusive manner to support team goals.

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.