The Process Engineer will provide technical and project engineering support to the site under the direction of the Senior Project Engineer. The Process Engineer will be responsible for driving existing HAZOP and PHA action items and projects to completion. The Process Engineer will work with internal customers and external service providers (architect / engineering firm, construction management firm, equipment suppliers). The Process Engineer will work in an office setting and in an active GMP manufacturing site.
Essential Duties and Responsibilities
- Consolidation, organization, and prioritization of existing HAZOP and PHA action items
- Procedural improvements and updates
- Management of small projects of low to medium complexity (scope development, design, specification, procurement, and installation coordination)
- Field coordination, verification, and oversight during installation
- Shakedown and commissioning of modifications to equipment and systems
- Scheduling support
- Change management support
- Identification and design of process changes required to satisfy HAZOP/PHA items
- Technical review and design support of other proposed changes
- Qualification Support
- Ensuring appropriate technical information and documentation is being requested / provided
- Support / challenge qualification decisions based on best practice / technical experience
- B.S. in Engineering or other technical education with adequate experience
- ≥ 5 years. The engineer should have knowledge of chemical processes and project execution in a GMP environment.
- Experience with process and operational safety standards – Hazard and Operability Studies and Process Hazard Analysis
- Analytical and troubleshooting skills, and a solid understanding of the main principles of process engineering.
- Experience with bulk pharmaceutical manufacturing
- “Hands on” experience starting up process lines: pumps, motors, agitators, valves, and instrumentation.
- Excellent communication and technical writing skills
- Able to read and understand P&ID’s and construction drawings.
- Experience with instrumentation, automation, or control systems (preferably Rockwell Automation / Wonderware).
- Proficient in Microsoft Office Applications (Word, Excel, Project).
- Detailed oriented.
- High, requiring knowledge of multiple technical disciplines and interaction with multiple departments in a team environment.
- High level of independence required. The engineer should be able to complete tasks ranging from low to medium complexity (multi-stage assignments) without requiring constant supervision or micro-management. The engineer should be dependable, motivated, and a self-starter.