Sterility Assurance Senior Expert

• Lead sterility assurance projects to ensure contamination control strategies (CCS) are effectively implemented and aligned with site objectives and regulatory requirements.

• Provide overall oversight of facility operations, ensuring compliance with sterility assurance standards and contamination control measures.

• Drive the implementation of sterility assurance programmes across facilities, collaborating with cross-functional teams site and above site teams to ensure consistency and effectiveness.

• Ensure facilities are maintained and operated in alignment with industry best practices, regulatory requirements, and contamination prevention principles.

• Collaborate with operations and quality teams to ensure contamination control measures are integrated effectively into manufacturing processes.

• Monitor performance metrics related to facility operations and contamination control, identifying areas for improvement and implementing corrective actions as needed.

• Act as the primary point of contact for sterility assurance within facilities, representing the team during audits, inspections, and internal reviews.

• Contribute to the harmonisation and continuous improvement of sterility assurance practices across the organisation, sharing knowledge and best practices.

• Develop and deliver training programmes, ensuring staff understand and consistently apply sterility assurance and contamination control measures.

• Support the strategic planning and execution of facility upgrades or projects to optimise contamination control systems and ensure regulatory compliance.

Basic Qualifications & Skills:

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related field

• Significant experience in sterility assurance within the pharmaceutical, biotechnology, or related industry

• Strong knowledge of regulatory requirements around sterility assurance and sterile manufacturing (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO).

• Excellent problem-solving skills and attention to detail.

• Strong leadership and project management abilities.

• Effective communication and interpersonal skills.

Preferred Qualifications & Skills:

• An advanced degree in Chemistry, Biochemistry, Microbiology, or a related field provides advanced knowledge of the scientific principles and methodologies that are crucial for ensuring product quality in the pharmaceutical industry.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.