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Process Safety Engineer - 13395 Job in Wilmington, Ohio US

Process Safety Engineer - 13395

Alkermes, Inc. - Wilmington, OH

Posted: 1/22/2025 - Expires: 2/21/2025

Job ID: 284375059

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Job Description

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
  • 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
  • Candidate must be willing to travel approximately 10-20%.
  • Collaboration, leadership, and influencing skills with strong customer service focus
  • Proficient in Office programs including Word, Excel, Access, Project, and PowerPoint

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

 

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 


Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.


Job Summary

Employment Type:
Full Time Employee
Job type:
Regular Employment
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
N/A
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 5
Graphic Literacy: 5

Workplace Documentation: 7