POSITION OVERVIEW

We’re 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 activities—from system assessments and protocol development through execution, documentation, and close-out—ensuring compliance with industry regulations and corporate standards.

MINIMUM QUALIFICATIONS

• Education: Bachelor’s 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

• 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 meetings—prepare 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.