The position is responsible for the Safety and Industrial Hygiene aspects for Parenteral Clinical Trial manufacturing and Packaging operations located in Indianapolis, Indiana. Primary responsibilities include creation and implementation of documents and procedures to enable successful facility startup and ongoing operational support.
The associate is responsible for ensuring that the goals of a safe and healthy work environment are achieved in an effective and conscientious manner. This role will provide assurance of compliance with all laws, statutes, regulations, and internal health, safety, and environmental standards. The position will also promote the safety culture across the organization by placing a primary focus on safety culture, accident prevention, hazard assessment and employee occupational safety and health. Willingness to work across functions and sites in a highly mobile environment is a key aspect of this position.
Key Objectives and Deliverables:
Major responsibilities include the administration of the following programs:
- Craft operational procedures appropriate for parenteral clinical trial manufacturing
- Execute commissioning and start up HSE reviews
- Collaborate with Quality Assurance/Quality Control aspects in implementing safe handling practices for potent active pharmaceutical ingredients
- Implementation of hazard communication program for R&D pharmaceutical compounds in a dynamic environment
- Provide incident review and follow up to safety incidents and actions reported via HSE Event Management system
- Execute qualitative and quantitative exposure assessment surveys to verify exposure control and containment of potent processes.
- Collaborate well with multiple team members and external HSE consultants, as needed.
- Point of contact for shared programs in parenteral clinical trial manufacturing including ergonomics, biological safety, and industrial safety programs
- Build and administer HSE training for personnel working in clinical trials
- Communicate workplace hazards to employees and management and inspire change when necessary
- Provide support to Lilly Research Lab CRO/CMO HSE Due Diligence program, as needed
Other responsibilities include execution of the following programs:
- Containment engineering
- Reproductive hazard reviews
- Accident investigation support
- Health and safety audit response
- Indoor air quality investigations
- Bachelor’s Degree in Industrial Hygiene, Environmental Health and Safety, Engineering or Sciences, or Other degree related to Health, Safety, and Environmental.
- 5 years pharmaceutical or chemical manufacturing experience. Parenteral, Clinical Trial, or R&D experience desired.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Masters degree preferred.
- HSE Professional Certification (CIH, CSP) preferred.
- The ability to communicate at all levels of the organization and to work as a team member is essential for this position.
- Proven skills in leadership and self-motivation.
- Attention to detail and ability to be flexible depending on operational needs.
- Effective communication skills (oral, written, presentation and negotiation) appropriate for all levels in the organization and a willingness to share information.
- A self-motivated, action oriented, high energy, team player with demonstrated ability to work effectively in a highly collaborative organizational culture where the primary decision-making process is building consensus.
- Practices and earns trust and mutual respect.
- Good interpersonal skills and effective time management, with a proven track record for being able to successfully manage multiple projects on a concurrent basis.
- High degree of business and personal ethics and integrity.