C&Q Engineer

Job Responsibilities

• Develop and execute Commissioning & Qualification (C&Q) protocols with minimal supervision.
• Take ownership of assigned systems, equipment, and project deliverables.
• Perform commissioning, qualification, and validation activities in compliance with project requirements.
• Document test results, deviations, investigations, and corrective actions accurately.
• Prepare and maintain validation documentation including risk assessments, test plans, protocols, and summary reports.
• Review and provide feedback on technical documentation prepared by junior engineers.
• Ensure all documentation is compliant, audit-ready, and aligned with regulatory standards.
• Coordinate C&Q activities with clients, vendors, contractors, and cross-functional project teams.
• Support project scheduling, resource planning, progress tracking, and status reporting.
• Identify project risks and proactively escalate issues while recommending solutions.
• Apply risk-based verification methodologies and industry best practices such as ASTM E2500 and ISPE guidelines.
• Ensure compliance with GMP, FDA, and other applicable regulatory requirements.
• Participate in and support internal audits, client audits, and regulatory inspections.
• Mentor and provide technical guidance to junior engineers and team members.
• Support knowledge transfer initiatives and contribute to team training efforts.
• Serve as a technical resource for commissioning, qualification, and validation activities.
• Manage multiple priorities and project timelines while maintaining quality standards.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 2–5 years of experience in commissioning, qualification, validation, or related engineering functions.
• Experience within pharmaceutical, biotechnology, chemical, life sciences, or regulated manufacturing environments.
• Demonstrated ability to independently manage assigned systems, equipment, or project scope.
• Knowledge of GMP regulations and FDA compliance requirements.
• Familiarity with industry standards and guidelines including ASTM E2500 and ISPE.
• Experience developing and executing validation and qualification documentation.
• Strong technical writing, documentation, and organizational skills.
• Ability to troubleshoot technical issues and implement effective solutions.
• Excellent communication and interpersonal skills with the ability to work effectively with clients, vendors, and cross-functional teams.
• Strong project coordination and time-management abilities.
• Experience using validation, quality, or project management tools such as Kneat and Smartsheet preferred.
• Ability to mentor junior engineers and contribute to team development.
• Ability to work on-site and support project execution activities in a regulated manufacturing environment.