We are seeking an accomplished and highly experienced Sterility Assurance & Contamination Control Lead to lead our comprehensive contamination control strategy within our sterile manufacturing operations. The successful candidate will be a recognized expert in GMP-regulated sterile environments, playing a critical role in ensuring the highest standards of product quality and regulatory compliance.

Your responsibilities will include,

• Proven experience in a GMP-regulated sterile manufacturing environment, including for example aseptic processing, terminal sterilization, or advanced therapy productS
• Demonstrated leadership in designing, implementing, and continuously improving a robust, site-wide Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 and global regulatory expectations (FDA, EMA, MHRA, PIC/S)
• Strong technical background in cleanroom design, qualification, and control, including state-of-the-art aseptic facility builds or major upgrades (HVAC zoning, material/personnel flows, RABS/isolator integration)
• Experience with regulatory remediation in sterile manufacturing — leading or supporting the recovery of compliance status, requalification of clean areas, and system-based corrective actions under regulatory oversight
• Demonstrated expertise in leading and resolving complex sterility assurance investigations: environmental or product contamination events, sterility test failures, media fill excursions, and utility-based contamination
• Deep understanding of aseptic operator qualification programs, aseptic technique training, gowning qualification, and personnel monitoring in controlled environments
• Familiar with quality oversight during tech transfer, facility startup, and process validation phases, ensuring sterility assurance is designed in from the outset
• Strong experience in cross-functional risk assessments (e.g., FMEA, HACCP) to proactively identify and mitigate microbial risks throughout the product lifecycle
• Able to critically assess trending data, EM programs, and facility/utilities performance to anticipate quality issues and drive preventive actions
• Experienced in preparing for and managing regulatory inspections and client audits with a focus on sterility assurance systems, contamination control, and aseptic practices

We are looking for someone with:

• Proven extensive experience in a GMP-regulated sterile manufacturing environment.
• Demonstrated leadership in designing and implementing Contamination Control Strategies.
• Strong technical background in cleanroom design, qualification, and control.
• Experience with regulatory remediation in sterile manufacturing.
• Demonstrated expertise in leading and resolving complex sterility assurance investigations.
• Deep understanding of aseptic operator qualification programs and personnel monitoring.
• Familiarity with quality oversight during tech transfer, facility startup, and process validation.
• Strong experience in cross-functional risk assessments.
• Ability to critically assess trending data and drive preventive actions.
• Experienced in preparing for and managing regulatory inspections and client audits.

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment  
• Flexible working arrangements and environment with an open culture and diverse workforce  
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options  
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit 

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!