Full-Time

Senior Manufacturing Compliance Engineer

Confirmed live in the last 24 hours

Sanofi

Sanofi

10,001+ employees

Develops pharmaceuticals and life-saving vaccines

Biotechnology
Healthcare

Senior

Framingham, MA, USA

Onsite presence required.

Category
Lab & Research
Life Sciences
Medical Research
Requirements
  • Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 3-4 years in a cGXP manufacturing environment or a Master’s degree in Sciences, Technical, Engineering or Advanced degree and 2 years of experience in cGXP manufacturing environment.
  • Knowledge and understanding of Manufacturing
  • Knowledge of GXP regulations and guidance.
  • Minimum of 2 years experience with deviation management systems (e.g. Trackwise).
  • Excellent critical thinking and technical writing
  • Excellent written and oral English language skills.
  • Proficient with change control requests, CAPAs and deviation quality systems
  • Proficient in critical thinking and technical writing
  • Experience leading cross functional teams and facilitating team meetings.
  • Ability to influence in a cross-functional environment.
  • Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents.
  • Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects
  • Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence, and delivers results on time.
  • Ability to work independently with minimal supervision to problem solve efficiently adhering to on-time delivery.
Responsibilities
  • Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines.
  • Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
  • Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
  • Conducts complex document revisions and /or document management including batch production records, manufacturing procedures, and cross functional procedures.
  • Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory and compliance.
  • Trains new Manufacturing Compliance Engineers.
  • Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
  • Works independently with minimal supervision and direction.
  • Participates in determining objectives of assignment.
  • Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion.
  • Effectively utilizes Microsoft office applications.
  • Creates and presents trending and metrics reports.
  • Provides direction to the Manufacturing Compliance Engineers in the absence of the operations manager.
  • Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget.
  • Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services.
  • Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results.
  • Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues.
Desired Qualifications
  • Bachelor’s degree in Biology, Chemistry, Biochemistry or Chemical Engineering.
  • Experience with project management
  • Experience in troubleshooting, investigation and root cause analysis in a GXP environment.
  • Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.

Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical conditions. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medicines, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and strategic partnerships, allowing it to maintain a diverse product pipeline and a global presence. The company's goal is to enhance health outcomes and improve the quality of life for individuals worldwide.

Company Stage

IPO

Total Funding

$2B

Headquarters

Paris, France

Founded

1973

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Simplify's Take

What believers are saying

  • Tolebrutinib's FDA Breakthrough Therapy designation boosts Sanofi's neurology portfolio.
  • Dupixent's EU approval for young children expands Sanofi's pediatric market.
  • Sanofi's partnership with BrightInsight accelerates digital health solution development.

What critics are saying

  • Liver enzyme elevations in tolebrutinib patients may affect market acceptance.
  • Increased competition in rare diseases from biotech startups challenges Sanofi.
  • Regulatory delays could impact Dupixent's approval for chronic spontaneous urticaria.

What makes Sanofi unique

  • Sanofi's Care4Rare program supports innovative solutions for rare diseases.
  • The MyWay app enhances patient engagement and medication adherence.
  • Sanofi's Muse AI tool optimizes patient recruitment in clinical trials.

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Benefits

Health Insurance

Professional Development Budget

Parental Leave