The Role
The Process Engineer ensures reliability and compliance of manufacturing processes in pharma/biotech, leading troubleshooting, validation, and quality assessments while collaborating across teams.
Summary Generated by Built In
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 experience in oral solid dose (OSD) processes, processes such as dry granulation,
mixing, compression, coating and packaging (preferably bulk packaging) and 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.
Requirements
- Bachelor’s degree in Engineering (Chemical,
Mechanical, Electrical, Industrial, Biomedical, or related field).
- Demonstrated strong experience in oral solid dose (OSD) processes, processes such as dry granulation,
mixing, compression, coating and packaging (preferably bulk packaging).
- 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.
Skills Required
- Bachelor's degree in Engineering
- Experience in process engineering
- Knowledge of 21 CFR Part 11 and GAMP
- Technical troubleshooting of equipment
- Project management experience
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
