CSV/PLC Validation Engineer

Position Overview:

We are seeking a knowledgeable and results-driven CSV 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:

1. Validation Strategy and Planning:

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   Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements.

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   Assess project scope, goals, and timelines to design efficient validation approaches.

2. Validation Execution:

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   Design, develop, and execute validation protocols, including IQ, OQ and PQ to verify system functionality and compliance.

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   Provide on-site or remote assistance during testing and data collection phases.

3. Documentation and Reporting:

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   Generate comprehensive validation documentation, such as validation master plans, Risk assessment/GxP Assessment, FS, CS, FRA, test scripts, 21 CFR PART 11 Assessment and validation reports.

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   Create clear and organized documentation that demonstrates compliance and traceability.

4. Change Control and Risk Management:

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   Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed.

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   Advise on the impact of changes and recommend appropriate validation strategies.

5. Regulatory Compliance:

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   Stay up-to-date with relevant regulations, guidelines (e.g.,21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.), and industry trends related to computer system validation.

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   Apply your expertise to guide clients in meeting regulatory requirements during the validation process.

6. Client Collaboration:

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   Build strong working relationships with clients, acting as a trusted advisor and validation expert.

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   Provide guidance, recommendations, and regular updates to ensure successful validation outcomes.

7. Training and Support:

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   Provide training to Perfect Utilities engineers involved in the validation process, empowering them to understand and implement validation principles.

8. Continuous Improvement:

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   Offer insights and suggestions for process improvement and optimization within the validation lifecycle.

Required Qualifications and Candidate Profile:

• Diploma, Bachelors Degree or equivalent in technical area preferred
• 1-5 years of hands-on experience in computer system validation of PLC based complex system preferably across different industries and systems.
• Knowledge of BMS, DCS, Lab Software Validation, Vision Software Validation.
• Being familiar with validation principles, regulatory requirements (e.g., 21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.)
• Proven track record of delivering successful validation projects and ensuring compliance.
• Excellent communication and interpersonal skills to collaborate effectively with diverse clients.
• Candidate should be ready for travelling across India.

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.