Trinity Consultants - Advent Engineering · 1 day ago
CQV Lead Engineer
Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expTrinity Consultants - Advent Engineering is seeking a CQV Lead Engineer responsible for the commissioning, qualification, and validation of facilities, utilities, process and laboratory equipment. The role involves authoring and executing CQV protocols, coordinating with cross-functional teams, and ensuring compliance with regulations and quality standards.
ConsultingLegalInformation Technology
Hiring Manager
Ana Bonilla
Responsibilities
Develop, review, and execute Commissioning, Qualification, and Validation (CQV) protocols including DQ, FAT, SAT, IQ, OQ, and PQ for biopharmaceutical process, facilities/utilities systems and Process/laboratory equipment
Generate documentation such as C&Q Plans and user requirement specifications (URS)
Support start-up and commissioning activities for upstream, downstream bulk processing equipment (bioreactors/fermenters, chromatography skids, bioreactors, TFF, UFDF, centrifuge etc.), solid/ oral dosage equipment (tablet press, powder compactors, coating pans, compounding skids for mixing, etc.), critical utilities (WFI, process gases, pure steam, etc.), FFIP (formulation equipment, isolators, fillers, lyophilizer, etc.), and/or equipment used in Single Use application (e.g., SUBs, SUM, etc.)
Perform equipment walkdowns, redline P&IDs, and verify component installations
Participate in and/or lead risk assessments and design reviews (FAT, HAZOP, etc.)
Coordinate with Quality Assurance, Engineering, Operations, and vendors to ensure timely execution of CQV deliverables
Identify and troubleshoot system discrepancies or failures during commissioning and qualification
Ensure adherence to project timelines and maintain clear communication across stakeholders
Generate and compile validation final reports, raw data, deviation records, and change controls
Support regulatory inspections by ensuring all validation documentation is complete and readily available
General working experience in Process Automation to support control narrative and sequences
Familiarity in process instrumentation and components for hygienic application
Familiarity with ASME BPE standards, ASTM E2500 risk-based C&Q strategies, ISPE and USFDA regulatory requirements
Qualification
Required
10+ years of experience in CQV or Validation within a regulated industry (pharmaceuticals, biotech, medical devices)
Hands-on experience with commissioning and qualification of systems such as bioreactors, chromatography skids, CIP/SIP systems, HVAC, WFI, Clean Steam, autoclaves, etc
Proficiency with Good Documentation Practices (GDP), FDA regulations (21 CFR Part 11/210/211), ICH Q8-Q10, ISPE Baseline Guides (e.g., GAMP 5)
Strong understanding of validation lifecycle and change control processes
Experience working with Delta V, PLC, SCADA, or other automation systems and PI Historian preferred
Excellent written and verbal communication skills
Strong analytical, organizational, and time-management skills
Strong troubleshooting skills to resolve issues and deviations observed during commissioning and qualification
Team-oriented but requires ability to work independently under limited supervision
Experience in consulting environment and engaging clients in projects that may have a dynamic schedule while multi-tasking other responsibilities is an asset
Bachelor's degree (B.S.) in Engineering (Mechanical, Chemical, Electrical, Biomedical) or Life Sciences (Biology, Chemistry, Pharmacy) from four-year college or university or foreign equivalent
Must have computer literacy, including word processing, spreadsheet skills, and knowledge of Microsoft Office software package
Ability to clearly communicate technical concepts, write detailed protocols and reports, and interact effectively with cross-functional teams, vendors, and regulatory auditors
Capable of drafting, reviewing, and revising high-quality validation documents, SOPs, and change controls in accordance with Good Documentation Practices (GDP)
Able to convey complex ideas to both technical and non-technical stakeholders, including during meetings, training sessions, and inspections
Strong analytical and problem-solving abilities are required to interpret engineering drawings, process data, and performance trends
Ability to interpret engineering documents such as drawings, piping lengths, welding requirements and modeling
Ability to perform engineering calculations related to flow rates, pressure drops, heat transfer, equipment sizing, and calibration tolerances to support commissioning and qualification activities
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
The employee must also be able to travel onsite at a client's location to perform the job duties
The employee must be willing to travel to client/vendor sites if required (FAT/SAT support or multi-site projects)
The position will be primarily onsite at GMP manufacturing facilities, laboratories, or construction sites
May require off-shift or weekend work depending on project timelines and system availability
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, outside weather conditions, risk of radiation, and vibration
The noise level in the work environment is usually moderate
Employee must be able to wear appropriate personal protective equipment (PPE) including gowning for cleanrooms
Preferred
Experience working with Delta V, PLC, SCADA, or other automation systems and PI Historian preferred
Advanced degrees or certifications in validation, quality, or project management (e.g., ASQ, ISPE) are a plus
Experience in consulting in Life Science industry and participate in delivering successful large-scale Engineering projects
Company
Trinity Consultants - Advent Engineering
ADVENT provides a wide array of services supporting the entire phase of the product lifecycle - from conceptual design through production.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ravi Baliga
CEO
Liz Wilson-SHRM CP
HR Business Partner, Life Sciences
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