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Lab QC CSV Engineer

Date Posted: February 22, 2024

Job Description

We are currently seeking a highly skilled Lead CQV Engineer to spearhead our commissioning, qualification, and validation efforts within the pharmaceutical sector. This pivotal role involves overseeing the CQV activities to ensure that facilities, systems, and equipment are properly commissioned, qualified, and validated in accordance with regulatory standards and industry best practices. Your leadership will be crucial in ensuring that our processes and operations meet the stringent quality requirements of the pharmaceutical industry.

Key Responsibilities

  • Lead the development and execution of commissioning, qualification, and validation strategies for pharmaceutical manufacturing facilities, equipment, and systems.
  • Oversee the preparation and review of CQV documentation, including plans, protocols, and reports, ensuring compliance with GMP guidelines and regulatory requirements.
  • Coordinate with project teams, engineering, operations, and quality assurance to ensure seamless execution of CQV activities.
  • Provide technical expertise and guidance on CQV best practices to internal teams and stakeholders.
  • Manage and mentor a team of CQV engineers and technicians, fostering a culture of continuous improvement and professional development.
  • Conduct risk assessments and implement risk management strategies throughout the CQV process.
  • Ensure timely resolution of issues and challenges encountered during commissioning, qualification, and validation activities.
  • Stay abreast of regulatory updates, industry trends, and technological advancements in CQV practices.

Required Qualifications and Skills

  • Bachelor’s degree in Engineering, Science, or a related technical field. Advanced degree preferred.
  • Minimum of 7 years of experience in CQV within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership role.
  • In-depth knowledge of GMP regulations, FDA/EMA guidelines, and industry standards related to CQV activities.
  • Strong leadership and project management skills, with a proven track record of leading successful CQV projects.
  • Excellent problem-solving, analytical, and decision-making abilities.
  • Effective communication and interpersonal skills, with the ability to collaborate across departments and levels.
  • Proficiency in CQV-related software tools and applications.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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