EHSS Specialist III

KBI Biopharma, Inc.; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an EHS&S specialist to lead the environmental, health, safety and sustainability program for our bioscience operations.

The role focuses on incident response, permit management, risk analysis and training to ensure compliance across the site. The ideal candidate will have a BS in a related field with 5–12 years of safety experience, preferably in biotech or pharmaceutical manufacturing, and hold key certifications such as OSHA 30 and HAZWOPER.

Qualifications

• Bachelor's degree in an occupational health and safety related field and a minimum of 5–10 years of industry experience as a safety professional.
• Bachelor of Science in a technical discipline with a minimum of 7–12 years’ experience as a safety professional in R&D and/or manufacturing.
• Preferred: Experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device). Knowledge of biotechnology/pharmaceutical operations.

Responsibilities

• Interface with KBI staff to maintain a positive, safe and compliant work environment.
• Co-chairs the EHS&S committee and provides regular status reports to system owners/managers.
• Coordinate and conduct internal self-audits and regulatory inspections as required.
• Respond to incidents, investigations and regulatory reporting; manage corrective actions.
• Represent KBI during OSHA, EPA, DOL inspections and client audits; ensure regulatory compliance.
• Draft and revise EHS&S policies, procedures and manuals to promote safe behavior.
• Coordinate EHS&S training and manage records (MSDS online, permits, logs, testing).
• Assess and specify PPE solutions for tasks and training needs.

Skills

Safety leadership

Regulatory compliance

Incident response

Education

B.S. in Occupational Health and Safety or related field

5–10 years of industry experience as a safety professional

B.S. in a technical discipline with 7–12 years’ experience

Tools

RCRA Hazardous Waste

DOT hazardous materials shipping

First Aid/CPR/AED

OSHA 30 General Industry

HAZWOPER 40-Hr

Job description

JOB SUMMARY

The specialist has responsibility for the implementation of the environmental, health, safety, and sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manufacturing organization. Responsibilities include: incident response, reporting and investigations; environmental permit management; and risk management. Implements all applicable EHS&S programs for the site such as: LOTO, confined space entry, industrial hygiene, hazard communication, PPE, workers compensation, emergency management, etc. Coordinates with operations to identify and mitigate risks with effective engineering controls, procedures, and training.

JOB RESPONSIBILITIES

Interface with KBI staff: High visibility in all workspaces to support a positive, practical, safe and compliant work environment.

Interface with Management: Communicate regularly with system owners or area managers to provide status reports, plan program activities and review EHS&S program effectiveness. Co-chair the EHS&S committee.

Assessments and Inspections

Coordinate and conduct regular internal self-audits and external client or regulatory inspections of systems as required by EHS&S procedures or programs.

EHS&S Incidents

Respond to reported Observations, Near Misses, Injuries and Spills, direct all reporting, assist employees and supervisors with investigations, preventative and corrective actions. Maintain regulatory reporting systems.

Regulatory Compliance

Represent KBI during OSHA, EPA, DOL or other regulatory inspections and client audits. Ensure that the staff understand requirements and operate the site in a compliant manner.

EHS&S Procedures

Draft, review and revise EHS&S systems, including policies, procedures and manuals to ensure that EHS&S practices are consistent with the applicable regulations and promote safe and compliant behavior.

Employee Training / Records Retention

Coordinate and provide training as needed for EHS&S programs. Maintain and manage EHS&S records including but not limited to MSDS online, waste management, chemical inventory, training records, environmental permits, inspections, OSHA Logs and testing.

PPE

Assess and specify appropriate PPE solutions for each task. Provide training as needed and monitor use.

Waste Management

Manage all waste activities including storage, treatment, disposal, and record keeping. Maintain business relationships with associated waste handling vendors.

Emergency Preparedness

Manage and maintain EHS&S supplies, equipment, materials and training as specified by EHS&S procedures or programs.

MINIMUM REQUIREMENTS

Knowledge, Skills, Abilities Qualifications: To perform this job 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience: Bachelor of Science degree in an occupational health and safety related field and a minimum of 5-10 years of industry experience as a safety professional, or Bachelor of Science in a technical discipline and minimum of 7-12 years’ experience as a safety professional in R&D and/or manufacturing.

• RCRA Hazardous Waste Management
• DOT hazardous materials shipping
• First Aid/CPR/AED
• 30 Hr General Industry OSHA Certification
• 40 Hr HAZWOPER certification

Preferred: Experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries). Knowledge of the operations typical to the biotechnology/pharmaceutical industry.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.