Validation Engineer
1 month ago
Job Description: Validation Engineer (Water System)
Location: Pune, Pharmaceutical Projects
Position Overview: We are seeking a skilled and experienced Validation Engineer specializing in Water Systems for our client's pharmaceutical projects in Pune. The ideal candidate will have 5-6 years of experience in validation processes, particularly within the pharmaceutical industry, and will ensure that all water systems meet regulatory and quality standards.
Key Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for water systems.
- Conduct risk assessments and ensure compliance with GMP, FDA, and other regulatory requirements.
- Perform validation activities including system qualification, performance qualification, and re-validation.
- Maintain accurate and detailed documentation of validation activities.
- Collaborate with cross-functional teams to ensure validation activities are integrated into project timelines.
- Troubleshoot and resolve issues related to water systems validation.
- Prepare and present validation reports to senior management and regulatory bodies.
- Stay updated with industry trends and regulatory changes affecting water systems validation.
Qualifications:
- Bachelor’s degree in Engineering, Biotechnology, or a related field.
- 5-6 years of experience in validation engineering, specifically in water systems within the pharmaceutical industry.
- Strong knowledge of GMP, FDA regulations, and other relevant standards.
- Excellent problem-solving and analytical skills.
- Strong communication and documentation skills.
- Ability to work independently and as part of a team.
- Preference will be given to candidates with local experience.
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