CQV Engineer - Intellectt INC
Boston, MA
About the Job
********** NO C2C Please ***********
Role: CQV Engineer
Location: Boston, MA
Duration: 12+ Months
Experience: 5+Years
Key Skills:
- Aseptic manufacturing
- CQV (Commissioning, Qualification, Validation)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- GMP compliance
- FDA regulations
- Aseptic fill equipment validation
- Utility validation (HVAC, water, steam, air)
- CQV documentation
- Risk assessment
- Root cause analysis
- CAPA
Qualifications:
Education: Bachelor's degree in a STEM-related field (Science, Technology, Engineering, or Mathematics)
Experience: 5 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
Key Responsibilities
- 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
Required Skills and Experience
- 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
Source : Intellectt INC