Job Description

Overview

This scope of work includes but is not limited to providing a lead personnel working as User

Representative/Engineer for Process/Plant Engineering

Scope/Responsibilities/Description

• Engineers must be able to act independently. They must be a self-driven engineer who can resolve barriers, manage contractors to execute the work, and has strong communication and organization skills
• Preferred engineers who have work in GMP environments
• Preferred a mechanical/civil engineer background (or chemical engineering with relevant experience)
• Project Scopes/Anticipated Projects :
• Corroded Piping Replacement/Repair

· Determine scope of piping that needs to be remediated due to corrosion

· Determine where the piping is located (behind walls/in gray spaces) and how to replace or repair the piping (remove walls/installation/passivation)

· Coordinate construction contractors

· Act as project manager by developing a timeline for the project and adhering to it

· Draft change controls as applicable

· Modify documentation as applicable (P&IDs, ISOs, validation (Kneat) documentation)

· Support Commissioning and Qualification activities

· Future Capabilities Project Scope:

• Installation of air sparge into a 15,000L tank
• Jacket a tank/or install a heat exchanger on a chromatography skid
• Draft documentation/user requirements for these two items in Kneat (Paperless Validation Software)
• Update P&IDs, drawings
• Determine how to implement in fieldUnderstand spare part requirements
• Coordinate construction contractors
• Support Commissioning and Qualification activities
• Railings
• Act as user rep for plant engineering
• Review the assessment generated related to all Work from Heights deficiencies per EDS-4202, corporate Eng, HSE and the design firm.
• Outline each deficiency and risk and present to the team to align on which items are in and out of this project scope and shutdown
• Work with the PM, Area owner, HSE and QA to create a timeline to implement each change.
• Execute changes
• Material Post Lifts
• Act as user rep for plant engineering
• Determine which material post lifts we should acquire / what remediation we should do based on discussion with local users and recommendations from post lift companies.
• Present suggestions to team and align on path forward, work with team to determine when to implement
• Develop User Requirements and complete the Design review in Kneat (Paperless Validation Software).
• Coordinate installation
• Complete Commissioning activities
• Update drawings

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