Senior Quality Engineer, Contamination Control

Job Title: Senior Quality Engineer, Contamination Control 

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Contamination Control Department supports quality and manufacturing activities at Sanofi Framingham Biologics Campus by identifying possible trends from microbial contaminants that may interfere with the quality of the product during different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the areas are operating in a state of environmental control.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Monitor metrics to evaluate effectiveness of contamination controls and continued sustainability.

• Actively participate and prepare information for the Environmental Action Committee (EAC)

• Prepare data for presentation at quarterly management reviews.

• Investigate and assess EM/CU excursions and determine appropriate CAPA.

• Provide trending for EM, and critical utilities monitoring in an accurate and timely manner.

• Writes Microbial assessments for bioburden recovery from the product/process.

• Ensures compliance with Sanofi and Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring.

• Acts as study director for critical utility risk assessments and/or EQ studies

• Determines sampling plans for utility and HVAC interventions and in process product monitoring and microbial controls (HACCP risk assessments)

• Perform contamination control walk through of clean rooms and utility systems; provide recommendations and track actions.

• Provide guidance ot production and facilities on contamination control requirements.

• Member of all Site Contamination Control Teams

• Key participant in working to resolve issues to the Site Contamination Control Lead

• Support the site Contamination Control strategy and plan resulting in reduced microbial risk.

• Support the Contamination Control Community of Practice (CoP) Network and assist in driving network improvements.

• Lead compliance with Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring.

• Lead site environmental and viral risk mitigation actions.

• Actively applies continuous improvement and Sanofi Manufacturing System (SMS) tools which improve reliability and capacity while ensuring quality.

About You

Basic Qualifications

• Basic: Masters with 7+ years, Bachelor’s with 9+ years, Associate’s with 11+ years, Experience in Quality Engineering/Assurance/Control and knowledge of cGXP regulations and biologics or similar manufacturing processes.

• Intermediate to advanced computer proficiency, strong verbal and written communication skills.

• Proven investigation skills.

•  Experience with quality systems and cGMP data review.

• Demonstrated knowledge of cGXP regulations and guidance.

• Demonstrated experience with change control, CAPA and deviation quality systems.

• Demonstrated proficiency in critical thinking and technical writing.

Preferred Qualifications

• Masters degree in a scientific field with 9 years of experience in Microbiology

• Experience in bio-pharmaceutical industry.

• Strong technical writing skills

• Effective time management, attention to detail, organizational skills, teamwork and collaborations.

• Demonstrated competence in problem solving methodology.

• Experience participating and/or leading cross-functional project team collaborations.

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