Global engineering & consulting firm specializing in pharmaceutical process design, commissioning, validation, and compliance.
Engineering support for pharma equipment commissioning, qualification, and project management
13 days ago ago
Junior (1-3 years)
Full Time
Boulder, CO
Office Full-Time
Company Size
250 Employees
Service Specialisms
Engineering
Consulting
Project Management
Design
Technical Services
Sector Specialisms
Pharmaceutical
Biopharmaceutical
Vaccine Manufacturing
Fill-finish Facilities
Process System Design
Commissioning
Qualification and Validation
Sanitary Design
Role
Description
walkdowns
commissioning
process engineering
sop review
cgmp compliance
documentation
Perform systems and P&ID Walkdowns
Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
Document, monitor, and report on project deliverables
Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
Perform several activities on clean water systems, compressed gases systems, CIP, mixing and storage vessels, distribution systems, and other pharmaceutical process equipment. Major activities include the following:
Review and modification of standard operating procedures (SOPs) for various equipment
Promote cGMP and regulatory compliance into assigned projects
Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment
Manage project documentation such as protocols, reports, calibration certificates, and process trends and be able to report findings to clients and vendors
Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs)
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Requirements
chemical engineering
safety
travel
communication
problem solving
compliance
Willingness to travel within the United States as needed
Effective written communication utilizing GDP; effective oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately
Ability to work on complex or undefined problems and quickly identify and address critical issues
Experience in construction safety and manufacturing safety
Ability to create an environment of trust, compliance, continuous improvement and learning
BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
Demonstrated ability to manage multiple priorities with aggressive timelines
Ability to relate with people at all levels within an organization, including diverse cultures
Benefits
Information not given or found
Training + Development
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Interview process
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Visa Sponsorship
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Security clearance
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Company
Overview
Founded 1993
Company Origin
The firm was established in 1993 as a boutique engineering consultancy.
2001 Global Expansion
Growth Milestone
The company expanded its operations globally, opening offices across three continents.
Revenue Millions
Financial Growth
Revenue has grown into the tens of millions, reflecting stable growth as a mid-market firm.
2020 Leadership
Succession Milestone
Key leadership transition occurred in 2020 with Kerren Bergman becoming president.
Began as a niche engineering consultancy focused on biopharma.
Operates 11 offices across North America, Europe, and Asia.
Primary focus areas include process system design, commissioning & validation, FDA compliance, and cleaning technologies.