Title: C&Q Engineer

Location: Puerto Rico (Open to local residents)

Positions: 1

Employment Type: Contract with ProQuality Network

Position Summary

ProQuality Network is supporting our client with a critical capital project and is seeking an experienced Commissioning & Qualification (C&Q) Engineer to provide advanced validation engineering expertise. This role supports complex, non-routine projects involving cGMP equipment, automation, facilities, and clean utilities, ensuring systems are designed, installed, operated, and maintained in a validated state.

The position applies risk-based Commissioning, Qualification, and Validation (CQV) principles aligned with ASTM E2500 and industry best practices, enabling efficient system implementation while maintaining full regulatory compliance.

Key Functions & Responsibilities

• Manage multiple projects or major portions of complex projects with demanding scope, schedule, quality, and technical objectives
• Develop and apply validation engineering practices that extend organizational knowledge in business-critical areas
• Define program objectives, requirements, and validation strategies
• Organize, plan, and coordinate work across multidisciplinary engineering and technical teams
• Develop standards, guidelines, and best practices for diverse C&Q and validation activities
• Resolve complex or non-routine technical challenges impacting major programs
• Maintain prompt and regular onsite attendance

Scope of Work

The C&Q Engineer will support cGMP automation, equipment, facilities, and clean utilities as part of a capital project executed by our client, under a contract with ProQuality Network. The role ensures alignment with risk-based CQV methodologies and regulatory expectations.

The primary objective is to demonstrate functional equivalency of new systems, accelerate implementation timelines, and avoid unnecessary validation studies while ensuring systems remain compliant and fit for intended use.

Specific Responsibilities

• Review and/or approve lifecycle documentation, including:
• User Requirements Specifications (URS)
• Risk Assessments and Data Integrity Assessments
• Commissioning & Qualification Plans
• Validation Plans
• Installation, Operational, and Performance Verification protocols and reports
• Clean Utilities documentation (e.g., APR, WFI, SCL, PW)
• Support field execution of commissioning and integration testing per approved C&Q plans
• Evaluate and approve protocol discrepancies and deviations, including direct Root Cause Analysis support
• Review engineering change notices and assess impacts to qualification strategies
• Participate in engineering design phases and recommend strategies to ensure successful qualification and startup, anticipating compliance risks
• Apply risk-based validation approaches aligned with internal SOPs and industry guidance
• Create and/or revise System Impact and P&ID drawings (approximately 65) for upstream and downstream impacted circuits
• Participate in project meetings, including detailed design technical reviews and slowdown window workshops
• Support and participate in risk assessments to identify hazards and implement appropriate controls
• Perform P&ID walkdowns with Engineering to determine impacted product and non-product contact systems
• Provide SME support during engineering phases, including:
• Basis and detailed design
• Risk assessments
• FAT, SAT, Set-to-Work, installation verification, functional testing, safety, and maintenance activities
• Provide Clean-In-Place (CIP) expertise, including cycle development, cleaning studies, worst-case determination, and protocol/report preparation
• Provide Steam-In-Place (SIP) expertise, including thermal mapping, biological indicator testing, microbial challenge studies, and protocol/report preparation
• Evaluate and document commissioning and qualification impacts to critical system changes through the Change Control Program, as required

Education & Experience Requirements

One of the following is required:

• Doctorate degree with 2+ years of directly related experience
• Master’s degree with 6+ years of directly related experience
• Bachelor’s degree with 8+ years of directly related experience
• Associate degree with 10+ years of directly related experience

Why Apply

This contract opportunity with ProQuality Network offers the chance to play a key role in high-impact capital projects within a regulated manufacturing environment, contributing technical leadership while partnering closely with cross-functional teams.