What You Will Do
Let's do this. Let's change the world. In this vital role you will focus on the development and implementation of EHSS programs aimed at enhancing business performance, driving continuous improvement, and fostering a culture of active care. Based on-site, this position will provide support to various functional clients, ensuring that EHSS requirements are implemented to the highest standards of performance.
The role involves reviewing all new or proposed changes to facilities, equipment, materials, or operations to ensure that all necessary EHSS requirements are thoroughly and rigorously addressed. The candidate will conduct regular assessments of procedures, practices, processes, related equipment, operator training, and other EHSS-related items.
The ideal candidate will excel in driving excellence, demonstrating strong leadership to influence clients and stakeholders to achieve top safety standards. They must balance accepting workable solutions with advocating for better alternatives.
A comprehensive understanding of the production facilities and laboratory operations for both small molecule and large molecule drug substances and drug products is essential to meet EHSS requirements in project design, delivery, and risk assessment program activities. The candidate is expected to drive significant change and improvement through proactive process enhancements and site support.
- Assess and implement ongoing improvement processes needed to enhance safety in manufacturing operations.
- Strong communication and interpersonal skills, able to build relationships with team members at all organizational levels and across Amgen.
- Serve as the main EHSS representative for small projects, providing formal EHSS reviews at Concept, Basis of Design, Detailed Design, and other stages as assigned.
- Review and provide EHSS input on project documents such as process flow diagrams, P&IDs, equipment specifications, and design drawings.
- Provide EHSS support by collaborating with Operations, Process Development, and Engineering. Interact daily with staff, engineers, and area management.
- Engage in global networks to provide expertise on cross-functional and cross-site issues.
- Perform incident investigations and root cause analysis, offering management support for the injury prevention program.
- Perform high hazard risk assessments using techniques like What If, HAZOP, and FMEA for EHSS and client deliverables.
- Develop, analyze and deliver insights on safety Key Performance Indicators (KPIs) utilizing data management systems.
- Assess Risk Program effectiveness, identify potential risks, and implement strategies to mitigate them.
What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The experienced EH&S professional we seek is an individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of EHSS experience; Or
Associate's degree and 10 years of EHSS experience; Or
Bachelor's degree and 6 years of EHSS experience; Or
Master's degree and 4 years of EHSS experience; Or
Doctorate degree and 2 years of EHSS experience
Preferred Qualifications:
- Degree in chemical engineering, mechanical engineering, process safety engineering, systems safety engineering, chemistry, biology or other science areas, or environmental, safety, or industrial hygiene
- 10 or more years of experience in Risk Management, including developing and implementing safety risk management programs in biotech/pharma
- Strong understanding of Chemical and Biological manufacturing (GMP and non-GMP) and laboratory operations.
- Applied knowledge and understanding of EHS principles and practices, regulatory standards, and requirements in context of business activities.
- Knowledge of regulations, standards and codes as they pertain to pharma/ biotech operations.
- Interpersonal skills to develop, coach and mentor other network colleagues in higher level Risk Assessment techniques and skills and some technical aspects of high hazard processes or activities (e.g. handling hazardous materials, use of high potency materials, control measures for handling exposable dusts or vapors, typical testing for reactive chemistry, electrical safety etc.)
- Ability to review and provide safety input on typical documents including process diagrams, P&IDs, equipment specifications, design drawings, etc.
- Knowledge of Process Hazard Analysis, HAZOP, What-If, PrHA, LOPA , SIL & FMEA
Benefits
For this position you must be currently authorized to work in the United States. We do not sponsor for this position.
Dakotah Gettler is recruiting for this position and the positions below.
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