EHS Specialist Pharmaceutical Manufacturing

POSITION SUMMARY

The Sr. EHS Specialist is responsible for complex technical work within a range of EHS disciplines.

The Sr. EHS Specialist will assist and support to the Associate Director of EHS in the development, implementation, and monitoring of the site's EHS programs designed to protect the health, safety, and well-being of all Ash Stevens employees, visitors, contractors, the Community, and the local environment as well as compliance with all relevant EHS regulations and best industry practices. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all applicable regulatory requirements, including

FDA, EPA, OSHA, MIOSHA, MI

DEQ, and related EHS procedures, policies, and practices.

• Consistent support of Ash Stevens' mission and values.
• Identify and protect the original technical information as part of the company property.

Key accountabilities:

• With limited supervision, assist and support the Associate Director of EHS with the development, implementation, and continuous improvement of all EHS management systems and programs.
• Support business plan KRAs/goals and develop and monitor to ensure goals are achieved.
• Develop implement, document, and periodically review Company training programs related to EHS to protect workers and satisfy regulatory and site requirements.
• Develop, review, approve and implement SOPs, Work Instructions, and all other EHS documents.
• Support site management with incident investigations, root cause analyses, and assignment & tracking of CAPAs as needed.
• Partner closely with internal cross-functional stakeholders to communicate, secure support, and inform the facility of EHS compliance risks and gain alignment on EHS initiatives and priorities.
• Ensure that the site complies with applicable EHS regulations and Company requirements, guidelines, and policies and takes the necessary steps to prevent non-conformances.
• Ensure that all EHS reporting, both internally and externally, is conducted timely and accurately.
• Assist with safety evaluations and risk assessments (JHA, PHAs, HAZOPs, FMEAs, PSSRs, etc.) of new products, processes, facilities, and equipment and recommend CAPAs to improve safety performance.
• Provide technical support for EHS programs (LOTOTO, Hazcom, Respiratory Protection, Chemical Hygiene, etc.)
• Assist with the development of annual EHS KRAs, goals, plans, objectives, and budget as directed by the AD.
• Complete requisite environmental reporting (Tier 2, biennial hazardous waste, air emissions, TRI, and stormwater) as directed by AD.
• Reporting injury/illness data electronically to OSHA & generating and posting requisite site reports
• Assigning and managing EHS education and training using MasterControl software system.
• Conducing new hire orientation (NHO) safety training and education as needed.
• Maintain and control site SDSs for RMs, SMs, IPs, and FPs per Hazcom Standards.
• Conduct qualitative/quantitative exposure assessments for hazardous materials and HPAPIs.
• Assessing site compliance with corporate policies/guidelines and federal, state, and local regulations through periodic workplace audits and walkthroughs (Gemba walks).
• Responsible for guiding Site Safety Committee (SSC) activities and initiatives.
• Work closely with Facilities, Engineering, Manufacturing, and Laboratory teams to ensure contractors and subcontractors work in compliance with all site EHS requirements (Safe Work Permits, PRCS entries, LOTOTO, hot work, etc.

)

EDUCATION/EXPERIENCE

• Bachelor's degree in EHS, Engineering, Chemistry, Industrial Hygiene, or similar degree required.
• Master's degree in EHS or related field preferred.
• Minimum of 5 years of EHS experience in a pharmaceutical manufacturing environment preferred
• EHS Certifications are a plus (CSP, CIH, QEP, CHMM)
• Sustainability & ESG experience are a plus.
• SDS authoring
• HPAPI containment and isolation equipment and practices.

JOB COMPETENCIES

• Excellent organizational and planning skills.
• Strong leadership and ability to influence all levels of employees.
• Strong problem solving/troubleshooting skills.
• Strong auditing and risk-assessment skills.
• Ability to self-lead work tasks to completion.
• Proficient in MS Office (Word, Visio, PowerPoint, & Excel), Emission Master, SAP, and Smartsheet.
• Strong written, verbal, and interpersonal communication skills.
• Excellent presentation and adult learning skills.
• Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Self-motivated and detail oriented.

Physical demands and work environment:

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands : o Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. o Long periods of sitting and walking may also be expected in this position. o This position may require long periods of sitting, typing, computer entry and/or looking at a computer screen.
• Work environment : o Ash Stevens is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing.

As such, all ASI staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. o Potential for limited exposure to hazardous chemicals and potent drug substances. o Personal protective equipment (PPE) including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate safety shoes may be required in areas associated with this position.

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Tuition reimbursement Vision insurance

Experience:

EHS:

5 years (Preferred) c

GMP or GMP:

1 year (Preferred)

Work Location:

In person