Production Specialist – Sterile Manufacturing

About the role

We are looking for a Production Specialist to join our sterile manufacturing team. You will ensure that all operations and product quality meet current Good Manufacturing Practices (cGMP), Ministry of Health regulations, and Environmental, Health & Safety policies. The role focuses on aseptic processes, cleanroom compliance, and continuous improvement.

Key responsibilities

• Ensure compliance with cGMP, GxP, and data integrity principles in sterile manufacturing.
• Monitor aseptic techniques, gowning qualifications, and cleanroom behavior in classified areas (Grade A/B/C/D).
• Perform Environmental Monitoring activities and evaluate results.
• Participate in Operational Excellence, productivity, and continuous improvement initiatives.
• Investigate deviations, including environmental excursions and sterility assurance.
• Monitor sterile product manufacturing according to the production plan (filling, lyophilization, terminal sterilization).
• Support or conduct media fill studies.
• Verify accurate completion of Batch Production Records and maintain Master Batch Records, SOPs, and related documentation.
• Train operators on updated procedures, aseptic practices, and contamination control.

Required profile

• Bachelor's degree in Bioengineering, Chemical Engineering, Chemistry, Pharmacy, or a related engineering discipline.
• Minimum 2 years of experience in sterile/aseptic pharmaceutical manufacturing.
• Strong knowledge of contamination control, cleanroom classifications, and aseptic processing.
• Advanced English proficiency.
• Proactive, solution‑oriented with strong communication skills.

Required skills

• SAP
• Werum PAS‑X
• Microsoft Office applications