Validation Engineer Jobs Opening in DIVINE SALES AND SERVICE at Ahmedabad-Others, Ahmedabad
Validation Engineer
Job Description
Strong documentation and analytical skills.
Ability to work in a team and independently with minimal supervision.
Key Responsibilities:
1. Validation and Qualification Activities:
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Develop, review, and execute validation protocols for equipment, processes, and cleanroom environments, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
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Conduct smoke studies to assess airflow patterns, contamination control, and cleanroom integrity.
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Perform calibration and qualification of critical instruments and monitoring systems used in cleanrooms.
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Ensure all validation activities are performed according to cGMP, ISO standards, and internal SOPs.
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Identify and document deviations and non-conformances during validation and qualification exercises and lead investigations to determine root cause.
2. Documentation and Compliance:
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Prepare detailed validation reports summarizing procedures, test results, observations, and conclusions.
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Maintain comprehensive documentation and records in compliance with regulatory standards to support audits and inspections.
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Review and approve validation documentation created by other teams or contractors.
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Ensure strict adherence to data integrity principles and electronic record compliance (e.g., FDA 21 CFR Part 11).
3. Regulatory Support:
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Stay current with regulatory requirements relevant to pharmaceutical manufacturing and cleanroom validation.
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Support internal and external audits by providing validation documentation and explanations.
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Assist in responding to regulatory agency queries related to validation and cleanroom compliance.
4. Cross-functional Collaboration:
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Work closely with Production, Engineering, Quality Assurance, and Facility Management to coordinate validation activities.
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Provide technical guidance and training to team members on cleanroom standards, validation protocols, and best practices.
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Participate in risk assessments and recommend corrective and preventive actions to maintain compliance.
5. Continuous Improvement:
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Identify opportunities to enhance validation processes, reduce risks, and improve compliance.
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Implement industry best practices and innovative validation techniques.
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Support qualification and validation of new equipment, technologies, and facility upgrades.
Required Skills and Competencies:
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Strong knowledge of pharmaceutical cleanroom classifications, environmental monitoring, and contamination control.
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Thorough understanding of validation lifecycle including IQ, OQ, PQ protocols.
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Familiarity with regulatory standards such as cGMP, ISO 14644, FDA guidelines, and EudraLex.
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Experience performing and interpreting smoke studies to validate airflow and pressure differentials.
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Proficiency in calibration of instruments and qualification of HVAC and process systems.
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Excellent documentation skills and ability to prepare regulatory-compliant validation reports.
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Analytical mindset with strong problem-solving and root cause analysis skills.
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Good communication skills for effective cross-departmental collaboration.
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Proficiency with quality management systems (QMS) and electronic document management.
More information about this Validation Engineer Job
Please go through the below FAQs to get all answers related to the given Validation Engineer job
- What are the job requirements to apply for this Validation Engineer job position?
- Ans: A candidate must have a minimum of fresher as an Validation Engineer
- What is the qualification for this job?
- Ans: The candidate can be a Graduate from any of the following: Diploma, Certificate Course (ITI), Other Post Graduate
- What is the hiring Process of this job?
- Ans: The hiring process all depends on the company. Normally for an entry level, hiring the candidate has to go for Aptitude, GD (If they look for communication),Technical test and face to face interviews.
- This Validation Engineer is a work from home job?
- Ans: No ,its not a Work from Home Job.
- How many job vacancies are opening for the Validation Engineer position?
- Ans: There are immediate 1 job openings for Validation Engineer in our Organisation.
Job Particulars
About Company
Ahmedabad 
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