Quality Assurance Engineer

6 days ago


New York, New York, United States Novozen Healthcare LLC Full time
About the Role

We are seeking a highly skilled Senior Validation Engineer to join our team at Novozen Healthcare LLC. As a key member of our pharmaceutical manufacturing team, you will be responsible for leading the planning and execution of commissioning, qualification, and validation activities for equipment, processes, and utilities.

Key Responsibilities
  • Commissioning and Qualification: Develop and execute IQ, OQ, and PQ protocols for new and modified systems, ensuring compliance with regulatory standards and internal quality policies.
  • Validation Documentation: Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Risk Assessment and Mitigation: Perform risk assessments, gap analyses, and provide mitigation strategies to ensure successful validation outcomes.
  • Collaboration and Communication: Collaborate with cross-functional teams (QA, Engineering, Manufacturing) to ensure timely and successful project execution.
  • Validation Master Plan: Support the development and maintenance of the Validation Master Plan (VMP).
  • Audit and Inspection Support: Participate in site audits and inspections related to CQV processes.
Requirements
  • Education: Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Experience: 4+ years of experience in CQV activities within the pharmaceutical or biopharmaceutical industry.
  • Regulatory Knowledge: Strong knowledge of regulatory requirements, including FDA, EMA, ICH Q7, and GAMP guidelines.
  • Technical Skills: Hands-on experience with validation of pharmaceutical equipment and processes, familiarity with GMP, GEP, and regulatory inspection processes.
  • Soft Skills: Excellent problem-solving skills, ability to work in a fast-paced environment, strong communication and organizational skills.
Preferred Skills
  • Computerized System Validation: Experience with CSV.
  • Cell and Gene Therapy: Experience in cell and gene therapy or biologics manufacturing environments.
  • Lean Manufacturing: Familiarity with lean manufacturing principles and continuous improvement methodologies.


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