CQV Lead Engineer

SUMMARY

The CQV Engineer is responsible for the commissioning, qualification, and validation of facilities, utilities, process and laboratory equipment, and computerized systems to ensure compliance with cGMP regulations and internal quality standards. This role involves authoring and executing CQV protocols (IQ, OQ, PQ), coordinating with cross-functional teams, troubleshooting deviations, and preparing documentation in support of regulatory requirements. The position plays a key role in delivering compliant operational systems for manufacturing and laboratory environments.

ESSENTIAL DUTIES AND 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.

SUPERVISORY RESPONSIBILITIES

May directly supervise a number of technical/CQV team members during Commissioning and Qualification phase of the project.

QUALIFICATIONS

• 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.

EDUCATION and/or EXPERIENCE

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.

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.

Must have computer literacy, including word processing, spreadsheet skills, and knowledge of Microsoft Office software package.

LANGUAGE SKILLS

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.

MATHEMATICALSKILLS

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.

REASONING ABILITY

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.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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).

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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.