Senior Engineer, Process Safety Specialist

7 days ago

Boston, Massachusetts, United States Takeda Pharmaceutical Full time

About Takeda Pharmaceutical

Takeda Pharmaceutical is a patient-focused company that inspires and empowers employees to grow through life-changing work. We foster an inclusive, collaborative workplace where teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Job Title: Senior Staff Engineer, Process Safety

We are seeking a highly skilled Senior Staff Engineer, Process Safety to lead our process safety team and activities. As a key member of our Synthetic Molecule Process Development (SMPD) team, you will be responsible for all aspects of process safety evaluation during different phases of process development.

About the Role

In this role, you will have deep experience in using relevant process safety analysis technologies and developing thermodynamic and kinetic models to reduce safety risks during development and scale-up. You will also be responsible for developing SMPD's process safety database and using an in-silico first approach to enhance process understanding while reducing the need for extensive experiments.

Your Key Responsibilities

  • Lead the process safety team & activities
  • Develop suitable workflows and fit-for-purpose, phase-appropriate testing plans for:
    • The identification of potential hazards of reactive chemicals, chemical reactions, and waste streams
    • The chemical hazard evaluation for combustible powders
    • Assessing material compatibility
  • Work with process chemists and engineers to perform a thorough evaluation of all known and potential hazards for the safe scale-up of chemical processes for preparing pharmaceutical intermediates and active products in both Takeda's research and manufacturing facilities
  • Collect and integrate relevant process safety data (e.g., calorimetry, pressure build-up, off-gassing) into digital platforms for seamless data analysis and sharing, ensuring data complies with FAIR principles (Findable, Accessible, Interoperable, Reusable)
  • Use thermokinetic software and in silico models to calculate critical process parameters, such as runaway reactions, Self-Accelerating Decomposition Temperature (SADT), and Time to Maximum Rate under Adiabatic conditions (TMRad), driving proactive safety interventions
  • Develop and manage centralized process safety databases, ensuring data is easily accessible and usable for predictive safety analysis, while also creating tools to support an in-silico first approach to process safety assessment, reducing the need for excessive physical experiments
  • Lead the development of digital protocols for conducting HAZOP analyses, utilizing data-driven insights to enhance hazard identification and risk mitigation in both new and scaled processes
  • Document and summarize safety results in an Electronic Lab Notebook (ELN) and generate comprehensive digital process safety reports, ensuring consistent and accessible data tracking and compliance documentation
  • Collaborate with cross-functional teams to embed data-driven process safety frameworks into the overall drug substance development lifecycle, from lab scale to full production
  • Collaborate with internal and external manufacturing teams, leveraging data analytics AI/ML and predictive modeling to ensure the safe scale-up of processes, identifying risks before scale-up stages
  • Review digital safety reports and data models to identify potential safety risks and design data-driven mitigation strategies, ensuring continuous process improvement and enhanced safety outcomes
  • Manage key vendor relationships and lead their engagement to carry out advanced process safety testing
  • Lead technology development and workflow initiatives to implement new capabilities and improve efficiency
  • Remain current on process safety science and technology
  • Maintain active involvement in key professional societies through conference participation and peer-reviewed publications

Requirements and Qualifications

We are looking for a highly qualified candidate with the following skills and qualifications:

  • A Ph.D. degree with 3+ years of industry experience; an MS degree with 9+ years of industry experience; or a BS degree with 11+ years of industry experience
  • Degrees in Material Sciences, Chemical Engineering, or Mechanical Engineering required
  • Previous experience in process safety in the pharmaceutical, agrochemical, fine chemical, or related industry required
  • Experience in HAZOPs and/or PHAs required, with a proven ability to lead safety assessments using digital tools
  • Previous experience with software packages for process safety prediction (e.g., AKTS, Aspen Plus, gPROMS) preferred, focusing on the prediction of thermal, chemical, and kinetic properties
  • Strong background in kinetic modeling and the use of mechanistic models for identifying critical safety limits in reaction chemistry, ideally for pharmaceutical or chemical processes
  • Experience in leveraging digitalization strategies, such as automated data pipelines, real-time monitoring systems, and AI-driven predictive models, to enhance process safety and reduce risk
  • Knowledge of in silico process development and the application of predictive models for proactive safety interventions and process optimization
  • Strong understanding of FAIR data principles (Findable, Accessible, Interoperable, Reusable) to drive efficient data management for safety modeling and analytics
  • Sound knowledge of current Good Manufacturing Practices (cGMP) preferred
  • Experience working in a pilot plant a plus
  • Previous experience with the use of contract facilities and managing technical transfers a plus
  • Experience in working in a multi-disciplinary team environment
  • Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts

Compensation and Benefits

For this role, we offer a competitive salary range of $133,000 - $209,000 per year, based on location and experience. Additionally, U.S.-based employees may be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.

Language

This job description is written in English, the original language code is en.

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