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Lab CSV Engineer

Date Posted: May 31, 2024

Job Description

We are looking for a detail-oriented Lab CSV (Computer System Validation) Engineer specialized in analytical lab equipment to join our Quality Assurance/Quality Control team. The ideal candidate will be responsible for ensuring that all laboratory analytical equipment and systems are validated and operated in accordance with regulatory standards and industry best practices. Your role will involve planning, executing, and documenting the validation activities for analytical lab equipment, contributing to the integrity and compliance of our testing processes.

Key Responsibilities

  • Develop and execute validation plans for analytical lab equipment and systems, ensuring compliance with GMP, GLP, FDA, EMA, and other relevant standards.
  • Conduct risk assessments for analytical lab equipment and systems to identify potential operational and compliance risks.
  • Design and perform qualification tests (IQ, OQ, PQ) for analytical lab equipment, including but not limited to HPLCs, GCs, spectrophotometers, and automated analytical systems.
  • Collaborate with laboratory personnel, equipment manufacturers, and IT teams to ensure seamless integration and operation of analytical lab equipment.
  • Prepare and maintain comprehensive validation documentation, including validation protocols, test results, and validation reports.
  • Review and update standard operating procedures (SOPs) related to the operation, maintenance, and calibration of analytical lab equipment.
  • Provide training and support to laboratory staff on the proper use of equipment and adherence to validation protocols and SOPs.
  • Monitor and evaluate new technologies and equipment for potential implementation in the laboratory, ensuring they meet validation requirements.
  • Ensure compliance with all applicable regulations, standards, and company policies throughout the validation process.

Required Qualifications and Skills

  • Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific field.
  • Minimum of 6 years of experience in lab equipment validation, specifically with analytical lab equipment, within the pharmaceutical, biotechnology, or related regulated industry.
  • Strong understanding of regulatory requirements and standards applicable to laboratory equipment, including GMP, GLP, FDA 21 CFR Part 11, and EudraLex Annex 11.
  • Proficient in validation methodologies and quality management systems.
  • Excellent analytical, problem-solving, and organizational skills.
  • Strong attention to detail and commitment to quality.
  • Effective communication skills, both written and verbal, with the ability to work collaboratively with cross-functional teams.
  • Proficiency in Microsoft Office Suite and experience with laboratory information management systems (LIMS).

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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