Director of Sterile Manufacturing – Technical Capability & Training

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Design and implement a comprehensive global strategy for technical training and capability enhancement in sterile manufacturing and contamination control.

• Create role-specific learning pathways, competency frameworks, and qualification programs across Manufacturing, Quality, Engineering, Microbiology, and Validation.

• Oversee the development and execution of technical training sessions, workshops, and initiatives aimed at building capabilities.

• Collaborate with global and site Subject Matter Experts (SMEs) to convert intricate scientific, engineering, and regulatory ideas into accessible learning formats.

• Develop a network of site Technical Training Single Points of Contact (SPOCs) to ensure cohesive capability development.

• Facilitate inspection readiness by integrating regulatory requirements and organizational learning into training programs.

• Analyze audit results, investigation patterns, and performance metrics to pinpoint capability deficiencies and foster continuous improvement.

• Encourage the sharing of best practices and standardization across a global manufacturing framework.

• Investigate innovative learning methodologies, including digital and immersive technologies, to elevate technical capability development.

⛳️ Requirements

• A Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Engineering, Biotechnology, or a related field.

• Extensive experience in sterile or aseptic pharmaceutical manufacturing, Sterility Assurance, Microbiology, Engineering, or a comparable technical area.

• In-depth understanding of contamination control, aseptic processing, sterile manufacturing, and international GMP standards, including EU GMP Annex 1.

• Demonstrated experience in creating and delivering technical training, competency programs, or capability-building initiatives.

• Strong capability to articulate complex technical ideas and engage stakeholders within a global organization.

• Established technical credibility along with exceptional coaching, facilitation, and mentoring abilities.

• Experience in supporting regulatory inspections, remediation efforts, and multi-site manufacturing settings is highly preferred.

🏝️ Benefits

• Competitive salaries

• Comprehensive benefits package

• Excellent opportunities for career advancement

• Initiatives promoting work-life balance

• An inclusive workplace environment

• Commitment to diversity and inclusion

• Equal opportunity employer