Sterile Academy & Sterility Assurance Specialist Fixed Term Contract

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is seeking a highly motivated and qualified individual to join our team as a Sterile Academy & Sterility Assurance Specialist (12 months fixed term contract). This is a unique opportunity to work with a world-class company that is dedicated to delivering flawless products and making a positive impact on the lives of millions.

Responsibilities:

• Execute Sterile Academy training modules and related reports (classroom and digital training organization).
• Collaborate with the QC Microbiological lab and Production teams to evaluate Environmental Monitoring data.
• Support the Sterility Assurance team in implementing the new Annex 1 guidelines including conducting GAP assessments and FMEAs to evaluate the risk of microbial pyrogen and particulate contamination. Additionally contribute to the development and implementation of the Contamination Control Strategy and CAPA plan.
• Evaluate Sterility Assurance topics related to new projects such as new departments manufacturing lines and processes/products introduced.
• Provide support for Sterility Assurance deviations and participate in regular oversight activities in the production department to improve and promote a culture of Sterility Assurance.

Requirements:

• Degree in Pharmacy CTF Biological Sciences Chemistry Industrial Chemistry Chemical Engineering or Biotechnology.
• At least 1-2 years of experience in the pharma/chemistry industry.
• Previous experience in the manufacturing of sterile medicinal products.
• Strong knowledge of aseptic processes Sterility Assurance concepts and microbiological notions.

Knowledge Skills Abilities:

• Excellent written and oral communication skills with the ability to interact effectively with all levels of management and personnel at the operating unit level.
• Fluent understanding of Sterility Assurance guidelines.
• Proficient in spoken and written English and Italian.
• Strong problem-solving and stress management skills.
• Ability to prepare technical documentation.
• Attention to details and precision.
• Organizational and presentation skills.

At Thermo Fisher Scientific Inc. we are committed to fostering an inclusive and diverse work environment. We are an equal opportunity employer and encourage qualified individuals from all backgrounds to apply. We are also dedicated to providing reasonable accommodations and adjustments for individuals with disabilities to ensure they have equal access to employment opportunities. Please let us know if you require any accommodations during the application process.