What are the responsibilities and job description for the CQV Engineer - Aseptic Fill Specialist - W2role position at TekOne IT Services Pvt. Ltd.?
Job Title: Validation Engineer/Specialist
Location: Atlanta, GA
Duration: 12 Months
Qualifications
Location: Atlanta, GA
Duration: 12 Months
Qualifications
- Education: Bachelor’s degree in a STEM-related field (Science, Technology, Engineering, or Mathematics).
- Experience: Minimum of 4 years providing Commissioning, Qualification, and Validation (CQV) services, preferably in the pharmaceutical or biotech industry.
- Aseptic Fill Experience: Strong knowledge of aseptic manufacturing processes and standards.
- Execute CQV Activities: Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for aseptic filling equipment and utilities.
- Validate Aseptic Fill Equipment: Ensure compliance with regulatory standards and Good Manufacturing Practices (GMP).
- Support Utility Validation: Validate systems such as HVAC, water, steam, and air supporting aseptic operations.
- Prepare Reports: Document validation results and investigate any issues.
- Conduct Risk Assessments: Identify risks or gaps and recommend improvements.
- Ensure Compliance: Adhere to GMP, FDA regulations, and other industry standards.
- Collaborate with Teams: Work with manufacturing, quality, and engineering teams to meet project timelines and standards.
- Extensive experience in aseptic fill facilities and knowledge of aseptic processes and equipment.
- Familiarity with clean and dirty utilities in aseptic manufacturing.
- Proficiency in preparing CQV documentation (execution protocols, validation reports, deviations).
- Strong understanding of GMP and regulatory requirements for aseptic environments.
- Problem-solving skills and ability to conduct root cause analysis and implement CAPA.
- Experience in an Aseptic Fill Facility.
- Familiarity with ISPE Guidelines and FDA 21 CFR Part 11.
