Job Description:
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
Position Summary
Alkermes, Inc. seeks an experienced Process Safety Engineer that is motivated, results driven, and passionate about EHS to support a pharmaceutical manufacturing site 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 internal and external 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
- Develop, review, approve, and implement SOPs and all other documents for Process Safety Management and Flammable Solvent handling
- Lead Alkermes Process Safety Management program covering drug substance and drug product manufacturing, working closely with Engineering, Manufacturing and Process Development at the Wilmington site
- 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
Requirements
Basic Qualifications:
- 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 and/or developing an OSHA Process Safety Management program in the pharmaceutical or chemical industry.
- Specific expertise in flammable liquids is required
Preferred Qualification:
- 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) a plus
- EHS experience in pharmaceutical manufacturing, medical devices, food/beverage, or similar industry a plus
- Strong problem solving and critical decision-making skills with the ability to develop multiple solutions to an issue and make valid recommendations for quick resolution
- Able to understand and execute processes including: recognizing internal customer needs, communicating process changes, measuring and assessing success and identifying areas for continuous improvement
- The position requires the ability to work well independently and in a cross-functional team environment
- Candidate must be a self-starter; highly detailed, and outcome focused
- Collaboration, leadership, and influencing skills with strong customer service focus
- Proficient in Office programs including Word, Excel, Access, Project, and PowerPoint
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
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Experience Level:
Mid-Senior Level
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