Commissioning & Qualification Engineer â Retained Sample & FG/WIP Cold Box Facilities & Utilities
Commissioning & Qualification Engineer â Retained Sample & FG/WIP Cold Box Facilities & Utilities
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Job Description
Position Overview
Were seeking an experienced Commissioning & Qualification Engineer to deliver end-to-end qualification and commissioning support for new cold box facilities utilities and automation systems at a major pharmaceutical manufacturing site. You will manage all C&Q activitiesfrom system assessments and protocol development through execution documentation and close-outensuring compliance with industry regulations and corporate standards.
Key Responsibilities
System Commissioning & Qualification
Lead C&Q of cold box chambers HVAC/dehumidification units air handling units chilled/potable water systems power distribution and other utilities.
Develop and execute IQ OQ and PQ protocols; compile FAT/SAT documentation.
Automation & Controls
Commission and validate BAS/SCADA control systems and HMI interfaces; test control logic and network communications.
Support data historian integration and reporting.
Documentation & Change Management
Create revise and manage C&Q deliverables (URS SDS trace matrices deviations/CAPAs).
Maintain documents in the quality management system and drive review/approval cycles.
Act as SME for change control events coordinating feedback from Quality Engineering IT and vendors.
Project Coordination & Reporting
Develop and maintain project schedules aligned to milestones; provide status updates at project meetings.
Organize kickoff sessions design reviews and weekly qualification meetingsprepare agendas and minutes.
Liaise with contractors and vendors to resolve technical issues and implement recommendations.
Quality & Compliance Support
Participate in data integrity assessments CAPA investigations and internal audits related to C&Q activities.
Ensure all activities adhere to internal procedures and industry guidelines for qualification and validation.
Minimum Qualifications
Education: Bachelors degree in Engineering (Mechanical Electrical Chemical or related)
Experience: 5 years in pharmaceutical or biotech commissioning & qualification including:
At least 2 years of computer system validation (CSV) support in a regulated environment
Hands-on experience with PLC SCADA DCS or BAS platforms
Proven track record executing IQ/OQ/PQ on facility utility and automation systems
Regulatory Knowledge: Familiarity with 21 CFR Part 11 GAMP 5 cGMP and good documentation practices
Technical Skills:
Proficient in Microsoft Office (Word Excel Project) and CMMS/document management systems
Ability to interpret P&ID diagrams and electrical/mechanical schematics
Soft Skills:
Bilingual English/Spanish with strong written and verbal communication
Excellent project management organizational and stakeholder coordination abilities
Flexibility to work non-standard shifts or extended hours as required
Preferred Attributes
Prior experience with Honeywell Experion or similar BAS platforms
Advanced data historian (e.g. OSI-PI) and CMMS configuration knowledge
Relevant professional certifications in automation or validation
To Apply:
Submit your rsum highlighting relevant cold box utility and automation C&Q projects and include a summary of your CSV and control systems experience.
Employment Type
Commission
