What are the responsibilities and job description for the Validation Engineer / Specialist position at TekOne IT Services Pvt. Ltd.?
Position: Validation Engineer / Specialist
Location: Atlanta, GA
Duration: 12 Months
Qualifications
Location: Atlanta, GA
Duration: 12 Months
Qualifications
- Minimum Bachelor’s degree in a STEM-related field (Science, Technology, Engineering, or Mathematics).
- At least 4 years of experience providing Commissioning, Qualification, and Validation (CQV) services, preferably within the pharmaceutical or biotech industry.
- Aseptic fill experience is essential, with a strong understanding of the processes and standards for aseptic manufacturing environments.
- Perform validation tasks like Installation, Operational, and Performance Qualifications (IQ, OQ, PQ) for aseptic fill equipment and utilities.
- Ensure aseptic filling equipment meets regulatory standards and GMP requirements.
- Assist in validating systems such as HVAC, water, steam, and air that support aseptic operations.
- Document validation results and prepare detailed reports, including any investigations of issues.
- Identify potential risks or gaps in current systems and recommend improvements.
- Make sure all work follows GMP, FDA regulations, and other industry standards.
- Work with manufacturing, quality, and engineering teams to ensure validation activities meet project timelines and standards.
- Extensive experience in an aseptic fill facility with knowledge of aseptic processes and equipment.
- Experience with clean and dirty utilities commonly used in aseptic manufacturing.
- Proficiency in preparing CQV documentation, including execution protocols, validation reports, and deviations.
- Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for aseptic environments.
- Strong problem-solving skills and the ability to conduct root cause analysis and implement Corrective and Preventive Actions (CAPA).
