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Jobs or company...

CQV Engineer

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Boston, United States of America
Salary undisclosed

Apply on

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  • 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
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