Position Summary

Alkermes, Inc. seeks an experienced EHS Professional with a focus in process safety engineering (PSE) that is motivated, results driven, and passionate about EHS to support a pharmaceutical manufacturing site based in Wilmington, Ohio. This role includes managing process safety, working closely with internal stakeholders, the development of engineering guidelines and EHSS risk management programs for handling/ processing proprietary products at all scales (development to commercial) within operations. This role is expected to promote EHS excellence and actively demonstrate leadership in all Process Safety interactions and activities.  This position involves work in design, operation, evaluation and improvement of flammable solvents, chemical and combustible dust processes, equipment, methods or products. Responsible to recommend appropriate practical improvements, recommend testing (when needed), and assist in the interpretation and application of technical information applicable to processing needs.

Key Responsibilities

• Support business plan goals; develop and monitor tasks to ensure goals.
• Lead Alkermes Process Safety Management program for the Wilmington site, working closely with Engineering, Manufacturing and drug product development.
• Develop, review, approve, and implement SOPs and all other documents for Process Safety Management and Flammable Solvent handling at site level.
• Manage multiple, often concurrent, projects and meet associated deadlines.
• Ensure that all Process Safety Management is conducted timely and accurately.
• Perform a variety of Risk Analysis Techniques including Dust Hazard Analysis and Hazardous Area Classification on Chemical and Combustible Dust Processing Systems.
• Assist with safety evaluations and risk assessments (JHA, PHA, etc.) of new products, processes, facilities, and equipment and recommend CAPA actions to improve safety performance.
• Provide technical support to Alkermes facility EHSS team and other stakeholders as required, including engineering/ process hazard reviews and incident investigation/ root cause analysis.
• Communicate across functions and disciplines, and present data to key stakeholders as required to drive Process Safety excellence.
• Develop Process Safety Information and Mechanical Integrity program, lead incident investigations and HAZOP studies and implement Management of Change system.
• Act as a business partner to departments of the facility that work with flammable solvents. 

Requirements

• Bachelor of Science (BS) degree in Mechanical or Chemical Engineering is preferred or another similar degree in Environmental Engineering or EHS
• Eight (8) plus years of implementing, developing and/or managing an OSHA Process Safety Management program in the pharmaceutical or chemical industry. Specific expertise in flammable liquids is required
• Certification in an EHS related discipline is a plus (CSP, CIH, and CHMM)

Knowledge/Skills

Knowledge of RAGAGEP, Recognized and Generally Accepted Good Engineering Practices, including but not limited to NFPA, API, ASME as they relate to PSM covered processes

Demonstrated competencies in Process Safety, including process safety testing and interpretation of results

Experience in Process Hazard Assessments, Dust and Fire Explosion, Hazardous Area Classification and Safety Controls for Flammable & Reactive Materials

Knowledge of NFPA standards, International Building & Fire Codes, OSHA Process Safety Management, Center for Chemical Process Safety Guidelines, and Hazardous Materials regulations

Knowledge of flammable solvents is required

Knowledge of current Good Manufacturing Practices (cGMP) or DEA Controlled Substances a plus