Global engineering & consulting firm specializing in pharmaceutical process design, commissioning, validation, and compliance.
Engineering support for pharma equipment commissioning, qualification and project management.
3 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
process engineering
equipment commissioning
fat execution
p&id walkdowns
sop review
cgmp compliance
Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment
Document, monitor, and report on project deliverables
Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Review and modification of standard operating procedures (SOPs) for various equipment
Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs)
Promote cGMP and regulatory compliance into assigned projects
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:
Manage project documentation such as protocols, reports, calibration certificates, and process trends and be able to report findings to clients and vendors
Perform systems and P&ID Walkdowns
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
Requirements
chemical engineering
safety experience
problem solving
travel
communication
project management
Ability to work on complex or undefined problems and quickly identify and address critical issues
Willingness to travel within the United States as needed
Experience in construction safety and manufacturing safety
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 relate with people at all levels within an organization, including diverse cultures
Ability to create an environment of trust, compliance, continuous improvement and learning
Demonstrated ability to manage multiple priorities with aggressive timelines
BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience