Manager, Environmental Health & Safety
Proclinical is seeking a Manager, Environmental Health & Safety with a leading biopharmaceutical company located in Philadelphia, PA.
- Completes hazard assessments, IH monitoring, process hazard analysis, life safety reviews, incident investigations, environmental regulatory field analysis, environmental reports, and permit applications.
- Reviews processes, facilities, procedures, and management of change documents to assure conformance to recognized EHS regulations, standards, and guidelines.
- Provides support in completing injury/illness analysis, training, self-assessments and addresses specific EHS concerns as they are raised.
- Performs area inspections for compliance including periodic documentation review; Supports implementation of compliance initiatives for operational areas.
- Leads the Safety Committee in developing an EHS self-assessment program and standards implementation tracking.
- Participates in regulatory inspections and assists in addressing noted concerns and citations.
- Depending on candidate experience, may serve as the company's Biological Safety Officer (BSO) and establish and chair the biosafety leadership team(s), impact decision making, and take an active role in promoting cross-site initiatives, teamwork, and collaboration across site functions.
- Develop, implement, and lead biosafety programs that minimize the risks of occupational exposure and ensure compliance with guidelines from the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), as well as a variety of local, state, and federal biosafety-related regulations.
- Oversee compliance as defined by the Bloodborne Pathogen and Aerosol Transmissible Disease Standards, Medical Waste regulations, and all other etiologic agents use requirements from federal, state, and local regulations.
- Provide technical and regulatory compliance, advice assessing physical and health risks associated with the use of potentially pathogenic microorganisms, human tissue or cells, and organisms containing recombinant or synthetic nucleic acid molecule research (R/SNA).
- Partner with scientific and business leaders to assess and mitigate biological risk and build consistency of expectations in the workplace.
- Advise on laboratory practices and establish procedures to handle employee exposure risks associated with human source materials, viruses, bacteria, and recombinant DNA activities.
- Improve biological safety risk assessment processes and inventory documentation as well as deliver hazard specific training.
- Primary system admin for the EHS system (Enablon) including technical and functional support for users.
- Manages user security, permissions, and location scope.
- Reviews data for quality and timeliness, and identifies all data gaps, outliers, and other concerns with users. Ensure consistent use among all sites.
- Generates procedures and training documentation for users.
- Assist teams with adding tasks, audits, and system changes.
- Generates output reports and dashboards using the appropriate BI tools; Tracks and communicates EHS score card metrics.
Skills and Requirements:
- Bachelor's degree required with concentration in safety, microbiology, environmental health, public health, chemical engineering, or a related technical discipline.
- RBP, CBSP, CIH, and/or CSP certification preferred
- Minimum 6 years' relevant work experience required
- 2 years' experience in system and data analytics or configurable cloud-based software, specifically related to safety and environmental performance and compliance, preferred.
- This position requires knowledge related to the use of biological agents and recombinant DNA in research and manufacturing settings. Requires expertise in Biosafety Level 1 and 2 (BSL-1 and BSL-2) containment and practices
- Technical/working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, OSHA BBP, and other regulations and consensus standards required
- Experience required identifying, evaluating, and controlling EHS and biosafety risks in the workplace
- Demonstrated ability to quickly interpret complex regulatory issues and provide recommended course of action
- Experience with cGMP environments, and pharmaceutical and/or biotechnology processes and R&D desirable
- Strong written and verbal communication skills with the ability to communicate clearly to all levels of the organization
- Self-motivated, flexible, creative, able to prioritize, and work in a fast-paced, dynamic environment and effectively deal with conflicting and changing priorities.
- Strong working knowledge of computers and programs including Microsoft Office, SharePoint, Teams, Enablon, etc.
- Excellent interpersonal, relationship management, organizational, and communication skills.
- Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
- Able to don cleanroom garments and personal protective equipment (scrubs, gowning coverall, masks, respirator, gloves, goggles).
- Able to see at near and mid-range with depth perception.
- Able to stand/sit/walk for long periods of time.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Able to move and lift 25 lbs.
If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) 617-671-0335 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.