Process Engineering Specialist

• Provide daytoday 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 startup 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 crossfunctional teams including Manufacturing Quality Assurance Engineering and Automation to ensure process robustness and compliance.
  

Requirements

• Bachelors 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 startups equipment commissioning and system upgrades.
  
• Proficiency in developing protocols SOPs risk assessments and validation documentation.
  
• Strong communication teamwork and leadership skills.