Company Description Valitronix Life Sciences Pvt. Ltd. is a specialized life sciences consulting company that delivers end-to-end validation and compliance solutions for the pharmaceutical, biotechnology, medical device, and healthcare industries. The organization supports clients in achieving regulatory compliance, operational excellence, and inspection readiness using scientifically sound, risk-based, and globally accepted validation methodologies.

Its expertise covers the full lifecycle of computerized systems, manufacturing equipment, laboratory instruments, automation platforms, utilities, and digital quality systems. Valitronix’s services align with international regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, WHO, MHRA, and ALCOA+ data integrity principles. The company emphasizes compliance as a foundation for quality, innovation, and patient safety while providing practical and sustainable solutions for highly regulated environments.

Role Description The Validation Engineer position at Valitronix Life Sciences is a full-time, on-site role. The office is located at Ahmedabad.

The Validation

Engineer will plan, execute, and document validation activities for systems, equipment, and processes in accordance with GMP and global regulatory guidelines. Daily responsibilities include preparing and reviewing validation protocols and reports, performing risk assessments, perform IQ-OQ-PQ testing, and providing help during issues identified in validation and qualification. The role involves close collaboration with cross-functional teams,



vendors, and clients to ensure inspection readiness, data integrity, and adherence to compliance standards.

The Validation

Engineer is expected to participate in internal audits, contribute to continuous improvement initiatives, and support training and knowledge-sharing on validation best practices. Qualifications

Bachelor's Degree or higher in Engineering (Electronics, Instrumentation, Electrical, Computer, Information Technology) or a related technical discipline.

1–3 years of experience in Computerized System Validation (CSV), Automation, or Validation within the pharmaceutical, biotechnology, medical device, healthcare, or other regulated industries.

Sound understanding of Data Integrity (ALCOA+), GAMP® 5, FDA 21 CFR Part 11, EU Annex 11, Good Manufacturing Practices (GMP), Good Documentation Practices (GDocP), and risk-based validation methodologies.

Working knowledge of Computerized System Validation (CSV) throughout the system lifecycle, including Validation Planning, User Requirements Specification (URS), Functional Design Specification (FDS), Design Qualification (DQ), Risk Assessment, Installation Qualification (IQ), Operational Qualification (OQ),



Performance Qualification (PQ), Traceability Matrix, and Validation Summary Reports.

Familiarity with industrial automation systems, including PLC, SCADA, HMI, DCS, Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and other GxP computerized systems.

Ability to perform functional verification, testing, troubleshooting, and documentation review to ensure systems operate reliably and comply with applicable regulatory requirements.

Robust analytical and problem-solving skills with the ability to evaluate technical documentation, identify compliance gaps, perform risk assessments, and implement effective corrective actions.

Excellent technical documentation skills with proficiency in preparing and reviewing validation protocols, reports, SOPs, specifications, and other quality documents.

Effective verbal and written communication skills, with the ability to collaborate across multidisciplinary teams and interact professionally with clients, vendors, and regulatory stakeholders.

Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) is preferred.

Willingness to travel to client sites for validation, qualification, audits, and project execution as required.

A proactive attitude, commitment to quality, integrity, continuous learning, and a customer-focused approach are essential for success in this role.

Salary: ₹3.0 LPA – ₹6.0 LPA (Depending on qualifications, experience, and technical competency)

📌 Validation Engineer (Ahmedabad)
🏢 Valitronix Life Sciences
📍 Ahmedabad