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EHS&S Specialist II

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Mar 19, 2024

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Discipline
Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

 

SUMMARY  The EHS&S Specialist II is a mid-level function within the BioMarin Environmental Health Safety and Sustainability (EHS&S) Department. This position is specialized in providing safety, health and environmental services to a manufacturing plant and other related departments in the biotech/pharmaceutical industry.    The EHS&S Specialist II works directly within the EHS&S Department. The EHS&S Specialist II will also work directly and indirectly with key stakeholders in GxP groups, such as manufacturing, building maintenance, plant maintenance, metrology, QC, and materials management. Other stakeholders include engineering, security, and capital projects personnel. The EHS&S Specialist I will also work directly with external consultants, contractors, and vendors.    The EHS&S Specialist II will function as a business partner to the manufacturing department, with an emphasis on the following services: incident management, comprehensive risk assessments & JHA’s, stakeholder engagement, waste management, regulatory compliance support, incident management ticket support, monthly safety assessment support and industrial hygiene.    At the discretion of the EHS&S Manager, the EHS&S Specialist II may also support other department initiatives such as industrial monitoring, training, program development and safety metrics reporting.     RESPONSIBILITIES  
  • Business relationship manager (“BRM”) for manufacturing operations, providing all manner of EHS&S support services, including: routine risk management services (e.g. JHA’s, assessments & routine safety, health & environment walkthroughs), 1x1’s with stakeholder leads and attendance at stakeholder all-hands meetings, training/program development, training delivery, INTELEX incident management system support, waste management program support, risk reduction/continuous improvement project support, monthly metrics and newsletter preparation/delivery and supporting numerous ad hoc inquiries from stakeholders.
  • Assists with providing comprehensive and in-depth knowledge of safety responsibilities, regulations, procedures, and business practices for biopharmaceutical manufacturing operations.
  • Conducts job hazard assessments (JHAs) related to biopharmaceutical manufacturing operations. Prioritizes, assigns and tracks JHA action items and work with stakeholders to ensure completion.
  • Coordinates and conducts safety audits/inspections.
  • Manage and lead internal EHS&S related projects; coordinate internal resources and processes to ensure projects are delivered on time and produce the desired results.
  • Initiates and/or supports routine safety review meetings with stakeholders.
  • Provides strategic support to Safety Committees. Works with Safety Committee leads to execute against goals, reduce safety risks to staff and improve safety awareness and culture. 
  • Works with internal and external EHS peers to support delivery of EHS services to the manufacturing department, including hazardous waste/hazardous materials management, strategic training program development/delivery, ergonomics, industrial monitoring, and SOP review.
  • Reviews new or proposed changes to site facilities, equipment, materials, or operations to determine all necessary EHS&S requirements are addressed.
  • Provides comprehensive knowledge of safety responsibilities, regulations, procedures, and business practices for biopharmaceutical manufacturing operations.
  • Reviews, updates and/or develops EHS&S policies and procedures. 
  • Performs and coordinates industrial hygiene assessments. Prepares assessment reports and coordinates communication of the assessment results.
  • Supports construction safety and contractor safety program efforts.
  • Reviews and provides EHS&S input on typical project documents including process diagrams, P&ID’s, equipment specifications, design drawings, etc.
  • Uses Personal Protective Equipment (PPE) as required, including a full-face respirator.
  • Becomes a certified member of the Emergency Response Team (ERT) and assists in ERT program planning. 
  • Maintains the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities.
  • Performs other tasks as assigned by supervisor.
EXPERIENCE  Required Skills:  
  • Required minimum EHS experience is dependent upon previously attained education level:
  • At least eight years prior experience with undergraduate degree.
  • At least five years prior experience required with an advanced degree.
  • Experience in the biopharmaceutical industry is required for this position.
  • Experience providing EHS services to manufacturing and/or other GxP functions is also required for this position.
  • Demonstrated ability to influence relevant site management, customers, and stakeholders, as appropriate, and to drive safety culture improvements.
  • Demonstrated ability to conduct comprehensive job hazard analyses, develop and support corrective actions based on findings.
  • Demonstrated ability to perform safety inspections in manufacturing, utility or warehouse environments as well as develop inspection checklist content.
  • Requires comprehensive and in-depth knowledge of EHS&S responsibilities, regulations, procedures, and business practices. 
  • Excellent written and verbal communication skills.
  • Strong public speaking skills to present at stakeholder, all-hands meetings, and training sessions.
  • Demonstrated ability and experience with developing and implementing tactical EHS programs.
  • Proficient in Microsoft Office software, including Outlook, Word, Excel, and PowerPoint.
  Desired Skills:  
  • Desired personal competencies related to performance in this role:
  • Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; establishes and maintains effective relationships with customers and gains their trust and respect. 
  • Planning: Sets objectives/goals; Breaks down work into the process steps; Develops schedules and task/staff assignments; accurately scopes out length and difficulty of tasks and projects.
  • Dealing with Ambiguity: Can shift gears comfortably; can effectively cope with change; can decide and act without having the total picture; can comfortably handle new projects with little instruction or guidance.
  • Organizing: Can orchestrate multiple activities at once to accomplish a goal; can marshal resources (people/funding/materials/support) to get things done; arranges information & files in a useful manner.
  • Motivating Others: Can motivate many kinds of staff, especially non-direct reports and team/project members; empowers others; is someone people like working with; invites input from each person and shares ownership and visibility.
  • Peer Relationships: Easily gains the trust and support of peers; is seen as a team player & is cooperative; can get unpopular objectives completed and be seen as fair.
  • Creativity: Comes up with a lot of new ideas/solutions; easily makes connections among previously unrelated notions; is seen as original and value-added in brainstorming sessions.
  • Initiative: Recognizes and acts on opportunities even when not asked to do so; self-directed within the scope of responsibilities.
  • Prior experience with the following software systems: EHS-MIS, accident/incident reporting and computerized maintenance management.
  • Familiarity with GxP regulations
  • Emergency Response Training
  EDUCATION  
  • Undergraduate degree, preferably in a science or engineering related field minimum requirement.
  • Professional certification such as CIH, CSP, CHMM, etc. preferred.
  • Advanced degree (e.g. Master’s) in a science or engineering field desirable.
  • Targeted training programs or professional certificates in an EHS-related discipline are also desirable.
  EQUIPMENT  Laptop computer, cell phone, radio, personal vehicle, PPE, and other environmental sampling and monitoring equipment as needed.    CONTACTS  The EHS&S Specialist II works directly within the EHS&S Department. The EHS&S Specialist II will also work directly and indirectly with key stakeholders in GxP groups, such as manufacturing, building maintenance, plant maintenance, metrology, QC, and materials management. Other stakeholders include engineering, security, and capital projects personnel. The EHS&S Specialist II will also work directly with external consultants, contractors, and vendors.    SUPERVISOR RESPONSIBILITY  This position can include supervisory responsibilities. If the Specialist II may supervise additional temporary staff and on-site consultants/vendors within their technical area of expertise.    SHIFT DETAILS   The normal working hours for this position are Monday through Friday, 8:00 am to 5:00 pm. This position provides EHS&S support for teams that work 7 days a week, 24 hours a day, across multiple shifts, there will be occasions when work is required outside the normal hours.      ONSITE, REMOTE, OR FLEXIBLE  This is a flexible role which requires work to be performed both offsite and with regular, intermittent onsite collaboration.  This role requires 3-4 days a week of onsite presence at a BioMarin location, as approved by the employee’s manager.     TRAVEL REQUIRED  This position does not require any regular travel.  

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.  

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
US

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