Automation Engineer / CSV / Equipment Validation Engineer
Job Description
Job Description
Position Summary:
We are seeking a highly motivated Automation/Validation Engineer with expertise in Computer System Validation (CSV), equipment validation, and automation systems. The role involves supporting commissioning, qualification, and validation (CQV) activities across equipment, facilities, and utilities, ensuring compliance with GMP regulations. Hands-on experience with Kneat (e-validation platform), DeltaV DCS, and preparation/execution of validation deliverables (URS, FAT, SAT, IQ/OQ/PQ) is required.
Key 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.
Qualifications & Skills:
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.
Preferred Experience:
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.