Process Engineering Specialist

The Process Engineer<\/b> 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<\/b>, computer system validation<\/b>, and technical troubleshooting<\/b>, supporting daily operations and continuous improvement initiatives to maintain regulatory compliance and operational excellence.

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Provide day to day troubleshooting<\/b> for manufacturing equipment, automated systems, utilities, and process deviations to ensure uninterrupted operations span span>

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Lead and execute the Computer Validation Life Cycle (CVLC)<\/b> for systems such as SCADA, PLCs, smart instruments, and networked control systems span>

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Develop and execute FAT, IQ, OQ, and PQ<\/b> protocols, including preparation of qualification reports and supporting documentation span>

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Prepare and maintain SOPs<\/b>, disaster recovery plans, backup strategies, and system configuration documentation span>

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Conduct Quality Risk Assessments<\/b> and Qualification Risk Assessments<\/b> for equipment, utilities, and computerized systems span>

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Support and manage engineering and validation activities for facility expansions<\/b>, new equipment installations, and system upgrades span>

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Perform commissioning, start up, and qualification<\/b> of critical utilities including HVAC, compressed air, purified water systems, and facility infrastructure span>

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Participate in investigations, CAPA development<\/b>, and root cause analysis for process, equipment, and system failures span>

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Review engineering drawings, P&IDs, material certifications, welding documentation, and construction packages for compliance and technical accuracy span>

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Collaborate in HAZOP<\/b>, hazard analyses, and safety assessments for new and existing systems span>

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Develop and maintain Calibration Programs<\/b>, HEPA filter certification processes, and software control systems span>

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Prepare Validation Master Plans<\/b>, analytical reports, and regulatory documentation to support audits and inspections span>

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Work closely with cross functional teams including Manufacturing, Quality Assurance, Engineering, and Automation to ensure process robustness and compliance span>

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Requirements<\/h3>

Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field).

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Demonstrated experience in oral solids manufacturing processes, specifically tablets<\/b>.

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Previous experience in handling problem solving and research associated with tablet manufacturing equipment and processes<\/b> (mixing, compression, coating, compaction in Roller Compactor)

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Extensive experience in process engineering<\/b>, validation<\/b>, metrology<\/b>, and quality assurance<\/b> within pharmaceutical or biotech manufacturing.

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<\/span span span span>Strong knowledge of 21 CFR Part 11<\/b>, GAMP<\/b>, and validation of automated systems (SCADA, PLCs, HVAC, water systems, utilities).

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Demonstrated ability to perform technical troubleshooting<\/b> on equipment and computerized systems.

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Experience with investigations, deviations, and CAPA management<\/b span>

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Experience in project management, facility start ups, equipment commissioning, and system upgrades.

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Proficiency in developing protocols, SOPs, risk assessments, and validation documentation.

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Strong communication, teamwork, and leadership skills.

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