Assoc. Dir., Safety & Environment
PharmaBiotechRegulatory AffairsQuality Assuranceemacroraveinformaws
Job description
Job Description The facility is executing multiple site-level capital projects that require Environmental, Health, and Safety (EHS) support through planning, design, and execution. This role provides comprehensive EHS guidance in alignment with regulatory requirements and Company standards, with emphasis on Process Safety Management (PSM). You will partner closely with engineering, facilities/maintenance, end users, quality, and other stakeholders to develop safe, compliant, and operable designs. The role operates with limited supervision and requires strong communication, collaboration, and problem-solving skills. Key Responsibilities: Serve as the EHS stakeholder across all project phases: concept, basis of design, detailed design, construction, commissioning, installation/operational qualification. Understand research lab operations and other end-user needs (including manufacturing and general site operations). Provide EHS guidance compliant with federal, state, and local regulations; Company standards, and applicable codes. Coordinate with EHS SMEs (IH, waste, water/sewer, hazardous/raw waste, ergonomics, biosafety, etc.) and technical design engineers to identify and implement compliant solutions. Support design compliance reviews and participate in GES Peer Reviews. Risk Assessment and Permitting Plan and conduct risk assessments using Company tools (e.g., IH or biosafety risk with our Company's professional support, ergonomics, machine guarding, equipment pre-startup reviews). Prepare clear reports of assessments, findings, and recommendations. Participate in hazard risk assessments for electrically classified areas per EL-901. Coordinate regulatory permitting with EHS SMEs (air, water/sewer, waste). Support EHS deliverables and workflows, including: EHSE Checklist and action item management MOC and action items (SMIS) Design compliance and peer reviews Process Safety and Loss Prevention Provide EHS/PSM technical guidance in PHAs (HAZOP, What-If), LOPA, FMEA, life safety, and loss prevention. Track PHA/LOPA recommendations to closure and support revalidations. Lead or support Pre-Start-Up Safety Reviews (PSSRs) and equipment safety inspections (ESIs). Act as a knowledge resource for Company and industry engineering and loss prevention standards. Coordinate project PSM documentation and closeout (PSM/PKM, Process Hazard Profiles). Construction, Commissioning, and Qualification (C&Q) Review and advise on C&Q Safety Plans. Support FAT/SAT planning (noise, ergonomics, pressure relief, fixed guarding). Conduct or support pre-mechanical, pre-dynamic, and pre-occupancy walkthroughs. Perform field ergonomic reviews, sound studies, IH surrogate testing, and related activities as required. Operational Readiness and Turnover Identify confined spaces; develop entry procedures per Company and legislative requirements; provide input on rescue planning. Review and develop HECPs and LOTO procedures; recommend devices/methods and create written procedures as needed. Review SOPs and advise on PPE requirements. Collaborate with Project Management, Engineering, and Construction leads to validate feasible, compliant solutions that support operability. Partner with Site EHS to transition ongoing Process Safety Management, Life Safety, and Loss Prevention responsibilities at project completion. Governance, Systems, and Reporting Utilize and help implement GES, our Company, and site-based systems for action tracking, incident reporting, metrics, and records, including PIMS, Eval/Kneat, Enablon, Cority IH, and Velocity, EHS Ergonomics. Provide weekly (and as-needed) project status updates in clear, consumable formats. Perform administrative duties to maintain accurate records, reports, and documentation. Manage multiple concurrent projects and deadlines with minimal supervision, exercise sound independent judgment. Regularly analyze and communicate data and project status to drive decision-making and achieve project goals. Perform other EHS responsibilities as assigned. Required Qualifications Bachelor’s degree in safety, Environmental Science, Engineering, or related discipline. Minimum 8 years of EHS experience supporting capital projects in R&D, manufacturing, or similar environments. Strong knowledge of OSHA, environmental regulations, and Company/site EHS standards, including: Industrial hygiene, ergonomics, general safety, hazardous work permits, life safety Process safety and PHA methodologies (HAZOP, What-If, LOPA, FMEA) Environmental permitting (air, water/sewer, waste) Familiarity with GES project timelines and related EHS deliverables. Experience with EHS/Project systems: PIMS, Eval/Kneat, Enablon, Cority IH, VelocityEHS Ergonomics, SMIS (MOC). Proficiency with Microsoft 365 (PowerPoint, Word, Excel, Outlook); Microsoft Teams and Cisco Jabber experience a plus. Key Skills and Competencies Excellent interpersonal, verbal, and written communication skills; able to develop materials and presentations for all levels. Demonstrated leadership, teamwork, and the ability to influence without direct authority. Strong analytical abilities and solid grounding in engineering fundamentals. Effective problem-solving with critical and innovative thinking. Highly organized; able to manage multiple complex workstreams and stakeholders. Customer service mindset and proven facilitation skills; adept at leading cross-functional meetings. Nice to Have (Optional) Experience in pharmaceutical, biotech, or highly regulated R&D/manufacturing environments. Prior involvement in commissioning/qualification and PSSR programs. Certifications such as CSP, CIH, CHMM, or equivalent. Required Skills: Biosafety, Environmental, Health, and Safety (EHS) Regulations, Environmental Health and Safety (EHS) Management, Environmental Management Systems (EMS), Environment Health and Safety, Hazardous Waste Management, Industrial Hygiene, Occupational Health Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal oppor
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