Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• At least 2 years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Strong understanding of IQ/OQ/PQ processes, GMP regulations, and industry standards, including ISPE Baseline Guides and ASTM E2500.
• Ability to read and interpret P&IDs, electrical schematics, and system design documents.
• Experience with automation systems, process equipment, and utilities in pharmaceutical or biotechnology manufacturing.
• Strong attention to detail and technical writing skills.
• Effective communication and teamwork skills.

Nice To Haves

• Experience with risk-based C&Q approaches.
• Familiarity with validation software tools for protocol development and execution.
• Project management experience in a schedule-driven environment.
• Knowledge of cleaning, process, and computer systems validation principles.

Responsibilities

• Plan, coordinate, and execute commissioning and qualification activities for equipment, utilities, automation systems, and facilities.
• Develop and review C&Q documentation, including protocols, test scripts, reports, and traceability matrices.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
• Ensure equipment and systems meet design specifications, user requirements, and applicable regulatory standards.
• Work with project managers, engineering, validation, automation, quality, and manufacturing teams to align on project timelines and deliverables.
• Troubleshoot and resolve issues identified during C&Q execution.
• Support change control, deviation investigations, and corrective/preventive action (CAPA) activities.
• Maintain compliance with GMP, safety, and environmental requirements throughout project execution.
• Ensure C&Q documentation is complete, accurate, and audit-ready.