• 
  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).
• 
  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.