Pune, Maharashtra, India
Not disclosed
On-site
Full Time
Job Description: We are looking for a motivated and detail-oriented CSV Engineer to support validation activities for GxP-regulated systems in the pharmaceutical domain. The ideal candidate will be responsible for ensuring computerized systems comply with regulatory requirements, including 21 CFR Part 11 , GAMP 5 , and Data Integrity principles. Open Roles: 🔹CSV Trainee – Freshers Educational Qualifications (for both roles): 🔹BE / Diploma (ENTC, Electrical, Electronics, Computer Engineering) 🔹B. Pharm / M. Pharm 🔹BCA / BCS 🔹MCA / MCS Mandatory Requirements (for both roles): 🔹Willingness to travel as per project needs (client sites, audits, etc.) 🔹Excellent communication and documentation skills 🔹Ability to work in a team-oriented, fast-paced environment Role-Specific Requirements: 📘 CSV Trainee (Freshers): Mandatory: Intermediate to advanced proficiency in Microsoft Word and Excel. Eagerness to learn pharmaceutical regulations, CSV lifecycle, and compliance standards. Good to Have: Basic knowledge of PLC, SCADA, GAMP 5, or automation systems. Understanding of the pharmaceutical manufacturing environment. Key Responsibilities: Assist in the creation of validation documents like URS, IQ, OQ, PQ, RTM. Support senior team members in validation execution. Participate in internal training programs. Learn industry regulations like GAMP 5 and 21 CFR Part 11. 🌟 What We Offer: Hands-on exposure to pharmaceutical and life sciences CSV projects Structured career growth, training, and mentorship Dynamic work environment and team culture Opportunities to work on-site with reputed pharma clients Show more Show less
Pune, Maharashtra, India
Not disclosed
On-site
Full Time
Job Description: We are looking for a motivated and detail-oriented CSV Engineer to support validation activities for GxP-regulated systems in the pharmaceutical domain. The ideal candidate will be responsible for ensuring computerized systems comply with regulatory requirements, including 21 CFR Part 11, GAMP 5, and Data Integrity principles. Open Roles: 🔹CSV Trainee – Freshers Educational Qualifications (for both roles): 🔹B. Pharm / M. Pharm 🔹BCA / BCS Mandatory Requirements (for both roles): 🔹Willingness to travel as per project needs (client sites, audits, etc.) 🔹Excellent communication and documentation skills 🔹Ability to work in a team-oriented, fast-paced environment Role-Specific Requirements: 📘 CSV Trainee Engineer (Freshers): Mandatory: Intermediate to advanced proficiency in Microsoft Word and Excel. Eagerness to learn pharmaceutical regulations, CSV lifecycle, and compliance standards. Good to Have: Basic knowledge of PLC, SCADA, GAMP 5, or automation systems. Understanding of the pharmaceutical manufacturing environment. Key Responsibilities: Assist in the creation of validation documents like URS, IQ, OQ, PQ, RTM. Support senior team members in validation execution. Participate in internal training programs. Learn industry regulations like GAMP 5 and 21 CFR Part 11. 🌟 What We Offer: Hands-on exposure to pharmaceutical and life sciences CSV projects Structured career growth, training, and mentorship Dynamic work environment and team culture Opportunities to work on-site with reputed pharma clients Show more Show less
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