Process Engineer

QRC Group, LLC•Carolina, PR

About The Position

The Process Engineer is responsible for ensuring the reliability, compliance, and performance of manufacturing processes, equipment, utilities, and computerized systems within a pharmaceutical or biotechnological environment. This role requires strong expertise in process engineering, computer system validation, and technical troubleshooting, supporting daily operations and continuous improvement initiatives to maintain regulatory compliance and operational excellence.

Requirements

Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field).
Extensive experience in process engineering, validation, metrology, and quality assurance within pharmaceutical or biotech manufacturing.
Strong knowledge of 21 CFR Part 11, GAMP, and validation of automated systems (SCADA, PLCs, HVAC, water systems, utilities).
Demonstrated ability to perform technical troubleshooting on equipment and computerized systems.
Experience in project management, facility start‑ups, equipment commissioning, and system upgrades.
Proficiency in developing protocols, SOPs, risk assessments, and validation documentation.
Experience with investigations, deviations, and CAPA management.
Strong communication, teamwork, and leadership skills.

Responsibilities

Provide day‑to‑day troubleshooting for manufacturing equipment, automated systems, utilities, and process deviations to ensure uninterrupted operations.
Lead and execute the Computer Validation Life Cycle (CVLC) for systems such as SCADA, PLCs, smart instruments, and networked control systems.
Develop and execute FAT, IQ, OQ, and PQ protocols, including preparation of qualification reports and supporting documentation.
Prepare and maintain SOPs, disaster recovery plans, backup strategies, and system configuration documentation.
Conduct Quality Risk Assessments and Qualification Risk Assessments for equipment, utilities, and computerized systems.
Support and manage engineering and validation activities for facility expansions, new equipment installations, and system upgrades.
Perform commissioning, start‑up, and qualification of critical utilities including HVAC, compressed air, purified water systems, and facility infrastructure.
Participate in investigations, CAPA development, and root cause analysis for process, equipment, and system failures.
Review engineering drawings, P&IDs, material certifications, welding documentation, and construction packages for compliance and technical accuracy.
Collaborate in HAZOP, hazard analyses, and safety assessments for new and existing systems.
Develop and maintain Calibration Programs, HEPA filter certification processes, and software control systems.
Prepare Validation Master Plans, analytical reports, and regulatory documentation to support audits and inspections.
Work closely with cross‑functional teams including Manufacturing, Quality Assurance, Engineering, and Automation to ensure process robustness and compliance.