CQV Consultant

1 day ago

Boston MA United States Azzur Group Full time

Azzur Group is a leading consulting firm specializing in life sciences, providing innovative solutions in Commissioning, Qualification, and Validation (CQV) to our esteemed clients. We are committed to delivering exceptional service and expertise, ensuring compliance with regulatory standards and optimizing operational performance. Join our dynamic team and contribute to the success of projects that make a difference.

We are seeking a highly skilled CQV Engineer to join our consulting team. The CQV Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, project management skills, and a thorough understanding of regulatory requirements.

Key Responsibilities:
  1. Commissioning, Qualification, and Validation:
    1. Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
    2. Coordinate and oversee the installation, testing, and validation of equipment and systems.
    3. Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP).
    4. Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments.
    5. Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports.
    6. Identify and resolve deviations and non-conformities, ensuring timely corrective actions.
    7. Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met.
    8. Provide technical guidance and mentorship to junior team members.
    9. Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities.
    10. Stay current with industry trends, technological advancements, and regulatory changes.
Qualifications:
  1. Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degrees are a plus.
  2. Minimum of 3-5 years of experience in CQV engineering, preferably within the pharmaceutical, biotechnology, or medical device industries.
  3. Demonstrated experience with commissioning, qualification, and validation of complex systems and processes.
  4. Strong knowledge of CQV principles, practices, and regulatory requirements.
  5. Proficiency in writing and reviewing technical documents and reports.
  6. Excellent problem-solving skills and attention to detail.
  7. Effective communication and interpersonal skills.
  8. Ability to work independently and as part of a team.
Certifications:
  1. CQV-related certifications (e.g., ASQ Certified Quality Engineer) are preferred but not required.
Benefits:
  1. Health Care Plan (Medical, Dental & Vision)
  2. Retirement Plan (401k, IRA)
  3. Life Insurance (Basic, Voluntary & AD&D)
  4. Paid Time Off (Vacation, Sick & Public Holidays)
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