Bachelor's degree in Engineering, Life Sciences, or related field preferred, or equivalent relevant experience.
5+ years in engineering, commissioning, qualification, or equipment implementation in a regulated environment.
Strong understanding of manufacturing equipment design, operation, and maintenance.
Demonstrated project engineering experience with startup and qualification processes.
Experience collaborating with vendors, engineering teams, and quality personnel.
Familiarity with CQV lifecycle activities, including FAT, SAT, and protocols.
Proficient in reading engineering documents and authoring CQV documentation.
Responsibilities
Provide engineering and CQV support for equipment implementation and modification.
Develop a comprehensive understanding of equipment design and functionality.
Act as a technical resource during all project phases, from design to qualification.
Review engineering and technical documents for accuracy and completeness.
Support design reviews, functional evaluations, and qualification requirements.
Coordinate with project stakeholders, including vendors and contractors.
Execute and support equipment commissioning, troubleshooting, and qualification activities.
Benefits
Opportunity to work in a dynamic and regulated production environment.
Engagement in multidisciplinary project teams for diverse perspectives.
Hands-on involvement during equipment installation and qualification.
Professional development through complex project challenges and vendor interactions.
Full Job Description
Roles & Responsibilities:
Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
Support FAT, SAT, commissioning, and qualification activities as required.
Author, review, and revise CQV and engineering documentation, including:
User Requirements Specifications (URS)
Commissioning protocols
IQ/OQ/PQ protocols and reports
Risk assessments
Traceability documentation
Engineering studies
Deviations and discrepancy documentation
Turnover and closeout documentation
Ensure commissioning and qualification activities are appropriately documented and executed in accordance with project requirements, site procedures, and cGMP expectations.
Manage assigned engineering/CQV activities against project schedules and communicate risks, issues, and progress to project leadership.
Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
Support investigation and resolution of technical issues encountered during commissioning and qualification.
Requirements:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
