Director, Process Safety Testing

The opportunity

The Director of Process Safety Testing & Process Engineering reports to the Head of Global EHS&S for TAPI, partners and works together with the EHSS Process Safety, R&D, MS&T and Operations experts to ensure safe operating processes and controls in the TAPI sites and promote an effective collaboration between all parts of these 3 departments locally, regionally and globally.  Provide EHS technical and managerial support to TAPI facilities, global process development and safety management related projects. Mentor, collaborate with Site’s EHS&S teams and train EHSS staff to build appropriate expertise and capabilities. Support Sites to evaluate chemical hazards, identify controls and mitigate potential impact in case of an event. Conduct reviews and assessments defined with company Guidelines, and participate and/or lead EHSS audits. Develop and or update Company guidelines to ensure requirements meet state of the art practices.

How you’ll spend your day

The Director of Process Safety Testing & Process Engineering will ensure that TEVA’s EHS&S standards, guidelines, processes and best practices are effectively implemented in TAPI. Support R&D teams to ensure they have Process Safety capabilities to test, generate and analyze data. Work together with the R&D project teams during chemical development, pilot development and scale up, reviewing the data generated during process research and development, setting minimal requirements and ensuring process safety testing and information are established at the right R&D stages, to prevent undesirable effects on production assets, ensure understanding if alarms, interlocks and controls are needed for safe process design, generate process insight knowledge.. Support MS&T teams and site EHS&S teams identify and request additional data when needed to ensure processes are intrinsically safe. 

As a member of TAPI, he/she will provide technical and managerial support to TAPI R&D center and facilities, on the following Process Safety and Process Engineering programs:

Support segment EHS&S Head in monitoring, assessing business impacts, determining necessary actions, and communicating to stakeholders changing or emerging laws and regulations related to Process Safety Testing & Process Engineering . Support TAPI TPO and CDMO program (e.g. assessment of API's Tech Transfer) to ensure minimum process data required is available. Ensure minimum Process Safety tests, Dusts and Explosivity data and chemical incompatibility assessments are available for safe guarding design of intrinsically safe processes is available (e.g. Emergency relief venting sizing), including innovative solutions to drive continuous improvement. Support the segment EHS&S Head in directing the sites to meet TAPI business EHS&S targets. Support segment EHSS Head in providing solutions, developing, measuring, analyzing, and communicating key performance indicators and metrics. Track developments and trends to support risk reduction and mitigation. Participate in Global EHS&S audits and EHS due diligence to CMO/ TPO and CDMO. Support TAPI R&D centers ensuring full and effective implementation of the Process Safety Management procedures established by Global EHS&S and the associated Global Engineering STDs. Support TAPI initiatives, projects and annual operating plan (AOP) to manage Process Safety risks, identifying potential opportunities for increased synergies and efficiencies, in line with segment objectives and targets, capital planning, and budget. Support Process Safety events investigations and related CAPA Plans.  Support competency building program in his/her area of expertise to enhance process safety capabilities at sites (e.g. understanding Process Safety tests, Dusts and Explosivity data, chemical incompatibility assessment, etc) At all sites within his/her remit, this role will ensure full and effective implementation of the policy, procedures and initiatives dictated by Global EHSS, promote compliance with objectives of the annual work plans, CAPA plans, increase the professionalism of the Site’s EHSS members & other managers and promote effective communications between all parts of the EHSS organization.

Process Safety testing and information responsibilities:

Ensure accurate Process Safety Data with Comprehensive Testing Capabilities Review reports and ensure R&D centers get proper testing and expert analysis essential to gather and apply this information in order to prevent fires, explosions and other major hazard events. Review EHS assessment for all new API molecules in the project development stage for all TAPI R&D centers. Review of Process Safety Information(Safety Report) for all stages of new products Review of lab testing data (DSC/TGA, RC1, & ARSST) of hazards in the process and the raw materials. Provide comprehensive testing review and direct to out in state-of-the-art laboratories by process safety experts and in accordance with local and international standards. Ensure Process Safety Information and library is maintained, and data collected to enable identification of potential risk factors inherent in handling, storing and processing hazardous substances and can be used to develop a robust process safety management system Ensure that review EHS&S assessment for all new API molecules in the project development stage for all TAPI R&D centers are completed and shared results with the receiving site. Ensure Process Safety Information (Safety Report) for all stages of new products are available and converted to Basis Of Safety Helps sites in developing testing capabilities and data interpretation competences. Support sites in the delivery towards external lab of Calorimetric and Process Safety testing if not run internally as needed.

Process Safety responsibilities:

Complete the initial process safety assessment to support and define product allocation review. Support the development of the preliminary assessment reports including processes requirements at Site level, with special focus on environmental and high potent hazard’s controls. Maintain internal database on safety reports and other relevant data reports on the different processes and ensure they are up-to-date.  Generate the list of HTHM (highly toxic and hazardous materials) and high hazardous processes commonly used in TAPI (like working with water reactive chemicals, Grignard, hydrogenations etc..), and develop best practices documents. Support the development of policies and procedures for the safe operation of equipment and facilities. Support sites completing/reviewing Process Hazard Analysis of highly hazardous processes (e.g., HAZOP) as required Be an active member of the Process Safety Technical Advisory Committee (PSTAC) and lead specific projects as required.

Process Engineering and Controls responsibilities

Support interpretation and implementation of Process Engineering issues during Process development and Tech Transfer products from sites (Manufacturing and/or R&D) and advice on the pros and cons of different technologies ( e.g. flow chemistry vs batch processes). Review EHS by Design requirements for Capital Expenditure Request (CER). Support TAPI's Global Engineering in review and development of Engineering STD and guidelines. Support key stakeholders evaluation related to process safety, technical and regulatory impact of proposed equipment and process changes and provide risk-based input on the decision process. Evaluate Process Safety risks from new technologies for possible applications in the workplace as required to support MS&T Develop and review HTHM best practices specifically for high risk and critical reactions (Azides, hydrogenations, …) to identify the right technologies and controls measures recommended. Ensure early identification of emerging regulations and preparation for remediation plan and developing gap/impact assessments. Support review of Teva’s internal or external engineering surveys.

Your experience and qualifications

Advanced knowledge and practical experience (at least 5 years) in the API Production operations. BE/BTech in Chemical Engineering, Chemistry or equivalent with at least 7 years' experience in a process engineering role with a pharma/chemical manufacturing plant Very experienced process engineer for API plant who serves as a recognised engineering specialist and a subject matter expert (SME) for API Processes and Equipment. Regional or multi sites experience in leading Process Safety and/ or operations in API. Process Engineering experience in building EHS by design and safe processes. Experience in Calorimetric and Chemical Process Safety testing analytics and process scale up. Experienced in HAZOP & PHA (Certified is preferred)

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