Process Engineering Specialist

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Job Description

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.

• 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.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field).
• Demonstrated  experience in oral solids manufacturing processes, specifically tablets .
• Previous experience in handling  problem solving and research associated with tablet manufacturing equipment and processes  (mixing, compression, coating, compaction in Roller Compactor)
• 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 with  investigations, deviations, and CAPA management .
• Experience in project management, facility start‑ups, equipment commissioning, and system upgrades.
• Proficiency in developing protocols, SOPs, risk assessments, and validation documentation.
• Strong communication, teamwork, and leadership skills

Additional Information

All your information will be kept confidential according to EEO guidelines.