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.

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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 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.

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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

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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

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To Apply:
Submit your résumé highlighting relevant cold box, utility, and automation C&Q projects, and include a summary of your CSV and control systems experience.