Project Engineer - Pharmaceutical Capital Projects (P&ID, URS, Commissioning)

Stark Pharma Solutions Inc; Spokane (WA); On-site; USD 90,000 - 125,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Project Engineer to support complex pharmaceutical capital projects from design through commissioning and startup.

You will develop and review P&IDs, URS, and engineering specifications, coordinate with vendors and contractors, and ensure GMP and regulatory compliance across multi-disciplinary teams. Responsibilities include managing scope, schedule and budget, guiding cross-functional groups, and providing technical leadership to ensure successful

Qualifications

• Bachelor's degree in Chemical, Mechanical or Process Engineering.
• Experience developing and reviewing P&IDs, URSs and engineering specifications.
• Experience with equipment selection, procurement, installation and vendor management.
• Commissioning and startup experience on pharmaceutical equipment and utilities.
• Experience developing RFQs and technical specifications for contractors.
• Project management experience covering scope, schedule, budget and risk.
• cGMP pharmaceutical manufacturing background.
• Must be legally authorized to work in the United States.
• W2 employment only.

Responsibilities

• Support engineering projects including equipment upgrades, process improvements, compliance initiatives, expansions and construction activities.
• Provide technical expertise in pharmaceutical manufacturing systems, equipment, utilities and processes.
• Develop and review P&IDs, URSs, engineering specifications and project design documentation.
• Support equipment design, selection, procurement and installation, working with vendors, contractors and internal stakeholders.
• Develop detailed specifications and RFQs for engineering firms, contractors and equipment manufacturers.
• Manage project scope, schedule, budget, risks, communication and documentation.
• Provide technical troubleshooting and engineering support through design, execution, commissioning and startup.
• Ensure projects comply with applicable GMP and regulatory requirements.
• Provide technical leadership and guidance to cross-functional project teams.

Skills

P&ID design

URS development

RFQ drafting

Vendor management

Commissioning

GMP knowledge

Project management

Regulatory compliance

Education

Chemical Eng

Process Eng

Job description

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Project Engineer - Pharmaceutical Capital Projects (P&ID, URS, Commissioning)

Job Summary

Our client, a pharmaceutical manufacturer, is seeking a Project Engineer to provide technical engineering support for complex pharmaceutical projects. The role supports capital initiatives, equipment upgrades, process improvements and multi-disciplinary project teams from design through execution, commissioning and startup.

Responsibilities

• Support engineering projects including equipment upgrades, process improvements, compliance initiatives, expansions and construction activities
• Provide technical expertise in pharmaceutical manufacturing systems, equipment, utilities and processes
• Develop and review P&IDs, URSs, engineering specifications and project design documentation
• Support equipment design, selection, procurement and installation, working with vendors, contractors and internal stakeholders
• Develop detailed specifications and RFQs for engineering firms, contractors and equipment manufacturers
• Manage project scope, schedule, budget, risks, communication and documentation
• Provide technical troubleshooting and engineering support through design, execution, commissioning and startup
• Ensure projects comply with applicable GMP and regulatory requirements
• Provide technical leadership and guidance to cross-functional project teams

Qualifications

• Bachelor's degree in Chemical, Mechanical or Process Engineering
• Experience developing and reviewing P&IDs, User Requirement Specifications and engineering specifications
• Experience with equipment selection, procurement, installation and vendor management
• Commissioning and startup experience on pharmaceutical equipment and utilities
• Experience developing RFQs and technical specifications for contractors
• Project management experience covering scope, schedule, budget and risk
• cGMP pharmaceutical manufacturing background
• Must be legally authorized to work in the United States
• W2 employment only