Responsibilities:

• Validation & Documentation.
• Author, review, and execute validation documentation including User Requirement Specifications (URS), Functional Specifications, Design Qualification (DQ), FAT, SAT, IQ, OQ, and PQ.
• Manage validation lifecycle documentation using Kneat.
• Perform risk assessments (FMEA, GxP impact assessments, traceability matrices.)
• Automation Systems (DeltaV & others.)
• Support automation projects involving DeltaV Distributed Control Systems (DCS), PLCs, and SCADA systems.
• Collaborate with automation and process engineering teams to ensure system integration, configuration, and qualification.
• Troubleshoot and support control system operations during commissioning and validation.
• Equipment & Utility Validation.
• Execute validation protocols for GMP manufacturing equipment, laboratory instruments, facilities, and utilities (e.g., purified water, clean steam, HVAC, compressed gases.)
• Support equipment qualification from FAT/SAT through operational readiness.
• Ensure systems meet regulatory requirements (FDA, EMA, ICH, Annex 11, 21 CFR Part 11.)
• Compliance & Quality.
• Ensure adherence to company quality standards and global regulatory requirements.
• Support audits and inspections by providing validation and automation documentation.
• Drive continuous improvements in validation strategies and procedures.

Requirements:

• Bachelor’s degree in engineering (Automation, Electrical, Mechanical, Chemical, or related field.)
• 3–7+ years of experience in automation engineering, CSV, or equipment validation within a GMP-regulated environment (biotech/pharma/medical device.)
• Proficiency with Kneat Gx for electronic validation document management.
• Hands-on experience with DeltaV DCS and automation systems.
• Strong knowledge of validation lifecycle (URS, DQ, FAT, SAT, IQ/OQ/PQ.)
• Familiarity with facilities & utilities systems (water systems, clean utilities, HVAC.)
• Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and FDA/EMA guidelines.
• Excellent technical writing, problem-solving, and communication skills.
• Experience in biologics, sterile manufacturing, or API facilities.
• Knowledge of MES, LIMS, and other GMP computerized systems.
• Prior involvement in CQV projects and capital projects.

• Validation & Documentation.
• Author, review, and execute validation documentation including User Requirement Specifications (URS), Functional Specifications, Design Qualification (DQ), FAT, SAT, IQ, OQ, and PQ.
• Manage validation lifecycle documentation using Kneat.
• Perform risk assessments (FMEA, GxP impact assessments, traceability matrices.)
• Automation Systems (DeltaV & others.)
• Support automation projects involving DeltaV Distributed Control Systems (DCS), PLCs, and SCADA systems.
• Collaborate with automation and process engineering teams to ensure system integration, configuration, and qualification.
• Troubleshoot and support control system operations during commissioning and validation.
• Equipment & Utility Validation.
• Execute validation protocols for GMP manufacturing equipment, laboratory instruments, facilities, and utilities (e.g., purified water, clean steam, HVAC, compressed gases.)
• Support equipment qualification from FAT/SAT through operational readiness.
• Ensure systems meet regulatory requirements (FDA, EMA, ICH, Annex 11, 21 CFR Part 11.)
• Compliance & Quality.
• Ensure adherence to company quality standards and global regulatory requirements.
• Support audits and inspections by providing validation and automation documentation.
• Drive continuous improvements in validation strategies and procedures