Aseptic Specialist – Pharmaceutical Manufacturing

About the role

AbbVie is seeking an Aseptic Specialist to join its Operations function. The role focuses on ensuring that all aseptic manufacturing activities comply with regulatory requirements and internal best practices, supporting the production of high‑quality sterile products.

Key responsibilities

• Act as the site Subject Matter Expert for aseptic manufacturing and microbiology.
• Ensure procedures meet GMP and aseptic regulatory standards.
• Apply risk‑management tools to drive sterility assurance and conduct operability assessments.
• Partner with quality, engineering, and aseptic mentors to support manufacturing shifts.
• Observe and coach shift teams on aseptic techniques during critical activities.
• Lead investigations of process or product issues, including media fills and environmental monitoring excursions.
• Own analysis, trending, and visualization of environmental monitoring data and develop corrective action plans.
• Represent the site in monthly aseptic reviews and drive continuous improvement of aseptic procedures.

Required profile

• Strong knowledge of aseptic manufacturing, GMP, and microbiology.
• Experience with risk‑management and sterility assurance concepts.
• Proven ability to lead investigations and implement CAPA.
• Excellent communication and teamwork skills.

Required skills

• Aseptic Manufacturing
• Good Manufacturing Practice (GMP)
• Risk Management tools
• Environmental Monitoring (EM) data analysis
• Microbiology
• Root Cause Analysis
• Corrective and Preventive Actions (CAPA)

What we offer

• Opportunity to work within a global biopharma leader.
• Collaborative environment focused on continuous improvement.
• Access to cutting‑edge technologies and professional development.