We are seeking a Process Engineer to support engineering services within a pharmaceutical manufacturing environment. This role will be responsible for process safety, equipment reliability, technical troubleshooting, and continuous improvement initiatives across plant-wide systems.
Key Responsibilities
- Manage Pressure Relief Systems, including troubleshooting PRD activations, conducting root cause analysis, and coordinating replacements to reduce plant downtime.
- Prepare, review, and validate ASME-compliant PRD calculations for rupture discs, PSVs, and other plant-wide systems, ensuring compliance with FDA, OSHA, and safety standards.
- Work closely with vendors, Engineering, and Procurement teams to resolve technical discrepancies during PRD procurement and ensure timely delivery of equipment.
- Support equipment specification finalization, technical clarification, and vendor coordination for engineering projects.
- Lead on-site verification and validation activities for PRD replacements, ensuring compliance with installation protocols and internal quality requirements.
- Participate in HAZOP / Process Hazard Analysis (PHA) activities to identify and mitigate process safety risks across API and sterile manufacturing processes.
- Support energy efficiency and sustainability projects, including HVAC optimization, airflow balancing, and retrofit initiatives.
- Develop and manage project timelines, budgets, and milestone tracking for energy-saving and engineering improvement projects.
- Ensure engineering activities are delivered in compliance with GMP, EHS, quality, and regulatory requirements.
Requirements
- Degree in Chemical Engineering, Mechanical Engineering, or related discipline.
- Experience in pharmaceutical, API, sterile manufacturing, or regulated manufacturing environments.
- Strong knowledge of pressure relief systems, PRDs, PSVs, rupture discs, and process safety standards.
- Familiarity with HAZOP, PHA, root cause analysis, equipment validation, and technical documentation.
- Experience working with vendors, procurement, engineering, and cross-functional project teams.
- Good understanding of compliance requirements such as FDA, OSHA, ASME, and internal safety standards.
- Strong problem-solving, coordination, and project management skills.