BioSpace
Principal Process Safety Engineer – BioSpace
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines, improve disease understanding, and give back to communities through philanthropy and volunteerism.
Lilly is currently constructing an advanced manufacturing facility for the production of API molecules. This facility will provide APIs for current and future products, including new modalities. This is a unique opportunity to be part of the leadership team for the startup of a manufacturing site, and the successful candidate will help build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.
Position Overview The Process Safety Engineer provides technical leadership in process safety management and engineering support across all phases of site development—from construction and startup through operations. The role is part of the HSE team and focuses on building systems, processes, and culture to support GMP manufacturing. During the project delivery and startup phase (expected 2029–2030), responsibilities will be dynamic and collaborative, requiring creativity and resilience to support organizational development and ensure readiness for full‑scale GMP operations.
Responsibilities
Support the development and implementation of the process safety management (PSM) readiness plan as a collaborative member of the HSE team.
Act as a key stakeholder in facility design, construction, and startup—providing input on process safety decisions to ensure compliance and alignment with project goals.
Oversee and support process hazard analyses (PHA) and facility siting studies.
Develop and implement core PSM elements, including employee participation, Management of Change, Pre‑Startup Safety Review, and PHA.
Train, mentor, and onboard staff to foster a strong process safety culture.
Provide oversight of API manufacturing operations.
Partner with Operations, Maintenance, and Engineering to manage change, ensure safe system implementation, and support startup readiness.
Ensure application of relevant industry codes and standards (e.g., NFPA 30, NFPA 652, overpressure protection) during projects and change reviews.
Build technical relationships with corporate and site process safety teams, and engage externally with organizations like CCPS, P2SAC, and ACC process safety groups.
Basic Qualifications
Bachelor’s degree in chemical engineering, chemistry, or related field of study; CCPSC or PE preferred.
3+ years of experience in chemical or pharmaceutical manufacturing.
Knowledge and experience in process safety, including knowledge of OSHA Process Safety Management (PSM) regulation.
Additional Preferences
CCPSC or PE strongly preferred.
Trained in Process Hazard Analysis, HAZOP, and What‑If Methodologies.
Strong analytical skills and a systematic, structured way of working.
Strong collaboration and communication skills.
Trained in Process Hazard Analysis facilitation.
Trained in Layer of Protection Analysis (LOPA).
Knowledge of EPA Risk Management Plan.
Experience interfacing with HSE‑related regulatory agencies.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines, improve disease understanding, and give back to communities through philanthropy and volunteerism.
Lilly is currently constructing an advanced manufacturing facility for the production of API molecules. This facility will provide APIs for current and future products, including new modalities. This is a unique opportunity to be part of the leadership team for the startup of a manufacturing site, and the successful candidate will help build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.
Position Overview The Process Safety Engineer provides technical leadership in process safety management and engineering support across all phases of site development—from construction and startup through operations. The role is part of the HSE team and focuses on building systems, processes, and culture to support GMP manufacturing. During the project delivery and startup phase (expected 2029–2030), responsibilities will be dynamic and collaborative, requiring creativity and resilience to support organizational development and ensure readiness for full‑scale GMP operations.
Responsibilities
Support the development and implementation of the process safety management (PSM) readiness plan as a collaborative member of the HSE team.
Act as a key stakeholder in facility design, construction, and startup—providing input on process safety decisions to ensure compliance and alignment with project goals.
Oversee and support process hazard analyses (PHA) and facility siting studies.
Develop and implement core PSM elements, including employee participation, Management of Change, Pre‑Startup Safety Review, and PHA.
Train, mentor, and onboard staff to foster a strong process safety culture.
Provide oversight of API manufacturing operations.
Partner with Operations, Maintenance, and Engineering to manage change, ensure safe system implementation, and support startup readiness.
Ensure application of relevant industry codes and standards (e.g., NFPA 30, NFPA 652, overpressure protection) during projects and change reviews.
Build technical relationships with corporate and site process safety teams, and engage externally with organizations like CCPS, P2SAC, and ACC process safety groups.
Basic Qualifications
Bachelor’s degree in chemical engineering, chemistry, or related field of study; CCPSC or PE preferred.
3+ years of experience in chemical or pharmaceutical manufacturing.
Knowledge and experience in process safety, including knowledge of OSHA Process Safety Management (PSM) regulation.
Additional Preferences
CCPSC or PE strongly preferred.
Trained in Process Hazard Analysis, HAZOP, and What‑If Methodologies.
Strong analytical skills and a systematic, structured way of working.
Strong collaboration and communication skills.
Trained in Process Hazard Analysis facilitation.
Trained in Layer of Protection Analysis (LOPA).
Knowledge of EPA Risk Management Plan.
Experience interfacing with HSE‑related regulatory agencies.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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