CSV/PLC Validation Engineer

1 month ago

ahmedabad, India Perfect Utilities Full time
*Please note this is not a software validation job. It is purely PLC/HMI Validation for Pharma Industry*
Position Overview
We are seeking a knowledgeable and results-driven Computer System Validation Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices.
Key Responsibilities
Validation Strategy and Planning:
Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements.
Assess project scope, goals, and timelines to design efficient validation approaches
Validation Execution:
Design, develop, and execute validation protocols, including IQ, OQ, PQ, and UAT testing, to verify system functionality and compliance.
Provide on-site or remote assistance during testing and data collection phases.
Documentation and Reporting:
Generate comprehensive validation documentation, such as validation master plans, protocols, test scripts, and validation reports.
Create clear and organized documentation that demonstrates compliance and traceability.
Change Control and Risk Management:
Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed.
Advise on the impact of changes and recommend appropriate validation strategies.
Regulatory Compliance:
Stay up-to-date with relevant regulations, guidelines (e.g., GAMP), and industry trends related to computer system validation.
Apply your expertise to guide clients in meeting regulatory requirements during the validation process.
Client Collaboration:
Build strong working relationships with clients, acting as a trusted advisor and validation expert.
Provide guidance, recommendations, and regular updates to ensure successful validation outcomes.
Training and Support:
Provide training to client personnel involved in the validation process, empowering them to understand and implement validation principles.
Continuous Improvement:
Offer insights and suggestions for process improvement and optimization within the validation lifecycle.
Qualifications
Bachelor's or Master's degree Engineering
2-3 years of hands-on experience in computer system validation, preferably across different industries and systems.
Deep understanding of validation principles, regulatory requirements (e.g., 21 CFR Part 11), and industry standards (e.g., GAMP).
Proven track record of delivering successful validation projects and ensuring compliance.
Excellent communication and interpersonal skills to collaborate effectively with diverse clients.
Proficiency in creating detailed validation documentation, including protocols, reports, and traceability matrices.
Familiarity with various software tools and technologies used in the validation process.
Benefits
As a valued member of our team, you will enjoy the opportunity to work with a range of clients, contribute to their success, and expand your professional network. We offer competitive compensation, a dynamic and supportive work environment, and the chance to make a meaningful impact in the industry by delivering exceptional validation services.
If you are a skilled CSV Engineer with a passion for assisting companies in achieving compliance and reliability in their computerized systems, we invite you to join us. Help us provide top-notch validation expertise and contribute to our clients' growth and success.
Salary
3 to 6 LPA CTC depending on experience/skills

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