Beschreibung

In this role, you will play a crucial part in ensuring sterility assurance by overseeing programs, conducting tests, and developing strategies to prevent contamination. Your expertise will guide the team in maintaining high standards in aseptic processes and compliance.

Anforderungen

• •Bachelor’s or Master’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
• •Understanding of scientific principles for manufacturing parenteral drug products
• •2+ years in pharmaceutical manufacturing
• •5+ years in pharmaceutical manufacturing
• •Strong interpersonal skills for cross-functional teamwork
• •Strong self-management and organizational skills
• •Strong oral and written communication skills
• •Experience with data analysis and trending

Aufgaben

• •Ensure oversight of sterility assurance programs on the manufacturing floor
• •Provide technical guidance for airflow pattern testing
• •Support environmental monitoring performance qualifications
• •Conduct aseptic process simulations
• •Implement cleaning, sanitization, and disinfection strategies
• •Oversee gowning procedures in GMP classified areas
• •Apply aseptic processing techniques
• •Develop contamination control strategies
• •Assist in facility monitoring for effective contamination control
• •Lead the development of the site's contamination control strategy
• •Provide expertise for cleaning and sanitization programs
• •Oversee the cleanroom gowning and aseptic technique strategy
• •Author and oversee environmental monitoring performance qualifications
• •Evaluate environmental monitoring data and create trend reports
• •Identify facility environmental isolates and maintain cultures
• •Author aseptic process simulation protocols and oversee execution
• •Evaluate aseptic process simulation data and author reports
• •Track aseptic process simulations to meet regulatory requirements
• •Apply sterility assurance risk management to manufacturing processes
• •Analyze microbial and manufacturing data for trends and improvements
• •Support root cause investigations for sterility assurance programs
• •Provide technical support during internal and external audits
• •Create and review technical documents related to sterility assurance
• •Collaborate with cross-functional teams to meet business objectives

Benefits