HSE Permit Writer

Role Summary

The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production building. A successful candidate will interface with the Process Team and Project Team to manage equipment availability. During the project delivery and startup phase (startup expected 2025 to 2027), roles will be fluid and dynamic as we build a new organization, implement the necessary systems and processes to support GMP operations, and foster a strong site culture.

Responsibilities

• Safe work permit preparation including the coordination of operations, project, and maintenance personnel.
• Execute the required safe work permits, including lock out tag out (LOTO), hot work, confined space entry, etc.
• Develop and maintain equipment specific instructions including lock-out, tag-out.
• Develop and maintain confined space entry risk assessments.
• Develop and maintain permitting equipment and supplies.
• Perform safety audits and maintain an audit ready status.
• Review and monitor relevant SOPs and SOP updates; execute unplanned SOP changes.
• Influence adherence to project and maintenance schedules.
• Support Process Engineers/Maintenance/Projects and Supervision in daily operations.
• Identify and support the implementation of improvements from Operations.
• Ownership of daily tasks, preventative maintenance or breakdowns.
• Conduct continuous improvement projects aligned with safety and quality expectations and operational needs.
• Understand Health, Safety & Environmental-regulated environment and apply Health & Safety/Process Safety standards.
• Understand other area processes and their hazards and respond appropriately.
• Participate in building and area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
• Follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements.

Qualifications

• Required: High School Diploma or equivalent
• Required: Legally authorized to work in the United States (no sponsorship expected)
• Required: Completion of Post Offer Exam or Work Simulation if applicable
• Required: Ability to effectively communicate (electronic, written, and verbal)
• Required: Basic computer skills (desktop software)
• Preferred: Previous experience in facility/area start-up environments
• Preferred: Previous experience in pharmaceutical manufacturing with PSM-regulated/hazardous chemicals
• Preferred: Solid understanding of FDA guidelines and cGMP requirements
• Preferred: Strong organizational skills and ability to prioritize multiple requests
• Preferred: Knowledge of lean manufacturing principles
• Preferred: Flexibility to troubleshoot and triage challenges
• Preferred: Ability to understand technical nomenclature and mathematical formulas
• Preferred: Manual material handling as appropriate
• Preferred: Physical ability to bend, reach, stretch, climb ladders, and work in tight spaces; stand for long periods

Education

• High School Diploma or equivalent

Additional Requirements

• Ability to work flexible schedules during startup period
• Ability to work overtime as required
• Work schedule: Monday through Friday, 8 hours per day; may include non-scheduled call-ins to respond to plant emergencies and some scheduled training