Develop and implement programs to ensure compliance with environmental government regulations. Administer and oversee Company safety programs and performance. Train relevant personnel in required safety and environmental procedures; maintain and update safety training and program documentation. Assume project responsibility for safety, health, and environmental-related programs.
Coordinate and conduct detailed phases of engineering work related to safety and environmental programs.
Serve as principal environmental resource, including the proper handling and disposal of regulated waste.
Ensure all environmental permits are current and relevant personnel are aware of requirements.
Serve as principal health and safety resource, and act as resource in establishing Company safety policies and procedures. Actively engages a network of advisors, internal and external, to cover consulting. Provides well thought out recommendations, promotes excellence in decision-making and fully participates in follow-on execution.
Conduct internal safety and environmental audits on a monthly basis; report findings and remediation plan.
Serve as liaison for external environmental, health and safety regulatory agencies, which includes onsite inspections- EPA, OSHA, FLDEP (Florida Dept of Environmental Protection); Local Regulatory Environmental Resources Dept. (RER) which was originally named DERM Department of Environmental Resource Management.
Perform related duties and special projects as required
Enforce compliance to safety procedures and programs in place.
Ensure all annual or bi-annual or other agency reports are completed and submitted in timely manner.
Work with site supervisors, managers or representatives to understand and investigate incidents as they occur.
Take proactive steps to develop and implement systems which shall prevent incidents.
Ensure all safety related procedures are kept up to date. . Identifies customers’ requirements and needs. Maintains thorough knowledge of healthcare industry trends and programs. Builds & maintains positive working relationship
Work with R&D to characterize new materials upon notification of their existence.
Judgment / Decision Making: Under general direction with periodic review of assignments. Complex work performed within a framework of functional policies and procedures requiring high degree of original thinking. Works cross-functionally with many internal groups- good communication and interpersonal skills. Ability to speak publically and train others a must.
Functional Expertise: Strong regulatory, compliance background with environmental and safety (industrial hygiene). Industrial hygiene background necessary for noise monitoring, air sampling, ergonomics or working with a contractor to monitor the same. Change management background with risk and safety impact to equipment and facilities also required.
Education & Experience:
Bachelor’s degree in Chemical or Environmental Engineering; Master’s degree and/or Professional Engineering License a plus. Seven years professional experience. Good communication skills; able to establish and maintain professional relationships. PC literate, with proficiency in MS Office application software. Knowledge of applicable FDA regulations and internal SOPs. Pharma industry experience is preferred such as a background working with active pharmaceutical ingredients. Medical Device background would also be acceptable. Experience and background in a manufacturing environment required, this is not limited to understanding how the product flows through the facility. Working knowledge of engineering design, automation and project management required. An electro-mechanical aptitude and experience is a plus. Role will be required to verify Equipment / Systems safety impact, with ability to determine safety adherence as part of the day to day job requirement.
Employer will assist with relocation costs.
Additional Salary Information: Base Salary, Bonus. Generous Benefits. Full Relocation package.
Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering pharmaceutical products that meaningfully benefit patients, with a commitment to advancing patient care through transdermal drug delivery.
Over 325 Noven colleagues are... working to advance our business and benefit patients at locations in Miami, FL and Jersey City, NJ. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's platform for U.S. prescription pharmaceuticals, helping Hisamitsu bring the benefits of patch therapy to the world.
Noven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami with capacity to produce several hundred million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.