What are the responsibilities and job description for the Validation Engineer position at Intellectt Inc?
Job Title: Validation Engineer Locations: New York & Mary Land Duration: 12 months
Overview: We are looking for an experienced Validation Engineer to lead and execute validation activities in the pharmaceutical industry. The role involves ensuring compliance with regulatory standards, developing and executing validation protocols, and driving process improvements.
Key Responsibilities
Overview: We are looking for an experienced Validation Engineer to lead and execute validation activities in the pharmaceutical industry. The role involves ensuring compliance with regulatory standards, developing and executing validation protocols, and driving process improvements.
Key Responsibilities
- Develop and execute IQ/OQ/PQ protocols for equipment, utilities, and processes.
- Lead process validation, risk assessment, and control strategy development.
- Ensure compliance with cGMP, FDA, and EU guidelines.
- Perform cleaning validation and Computer System Validation (CSV) following GAMP 5 guidelines.
- Investigate deviations, implement CAPAs, and ensure data integrity.
- Lead validation projects, manage timelines, and collaborate with cross-functional teams.
- Support regulatory inspections and audits with thorough documentation.
- Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related field.
- 5-8 years of validation engineering experience in the pharmaceutical industry.
- Strong knowledge of cGMP, FDA, EU regulations, and validation standards.
- Proficiency in IQ/OQ/PQ protocols, cleaning validation, and CSV.
- Strong project management, analytical, and problem-solving skills.
- Excellent communication skills and attention to detail.
- ASQ Certified Quality Engineer (CQE) or equivalent certifications.
- Experience with validation software tools like TrackWise or ValGenesis.
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