Computer System Validation Engineer

Company Description

iPharmatec Solutions (IPTS) is an international consultancy providing cGMP compliance, CQV, computer system validation, and engineering consulting services to pharmaceutical, biopharmaceutical, and medical device industries. We help clients design, build, and operate manufacturing facilities that adhere to international cGMP regulations, offering them a competitive edge.

Our services include CQV execution and management, computer system validation, temperature mapping, cleanroom and HVAC qualification, risk-based validation, GMP compliance services, facility design, and regulatory submission services. Our mission is to ensure operational efficiency, compliance, and successful project outcomes for our clients.

Role Description

This is a full-time on-site role for a Computer System Validation Engineer based in Baddi. The Computer System Validation Engineer will be responsible for validating and ensuring compliance of various computer systems including PLC, HMI, SCADA, LIMS, ERP, and MES, among others. Daily tasks will include creating and executing validation protocols, performing risk assessments, ensuring 21CFR part 11 and GAMP5 compliance, and drafting validation documentation such as URS, EDS, FAT, SAT, IQ, OQ, PQ. The role also involves collaborating with cross-functional teams to support project commissioning, qualification, and validation activities.

Qualifications

• Strong experience in Computer System Validation, including PLC, HMI, SCADA, LIMS, ERP, and MES validation
• Familiarity with GAMP5, 21CFR part 11, and other relevant regulations and guidelines
• Experience in drafting and executing validation protocols (URS, EDS, FAT, SAT, IQ, OQ, PQ)
• Solid understanding of risk assessments (FMEA, HAZOP, HACCP, etc.)
• Excellent project management and organizational skills
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively in a team environment
• Bachelor's degree in Engineering, Computer Science, or a related field
• Experience in the pharmaceutical, biopharmaceutical, or medical device industries is a plus