CSV Engineer (Pharma) (US)
Date Posted: November 2, 2024
Job Description
We’re seeking a skilled CSV (Computer System Validation) Engineer to join our pharmaceutical team in the US. As a CSV Engineer, you will be responsible for ensuring that all computerized systems within our facility meet industry regulations and standards, ensuring data integrity, and maintaining compliance with regulatory requirements. Your role will be critical in supporting our commitment to quality and operational excellence.
Key Responsibilities
- Develop and execute Computer System Validation (CSV) strategies, plans, and protocols for pharmaceutical systems, including laboratory systems, manufacturing execution systems (MES), and enterprise resource planning (ERP) systems.
- Ensure compliance with regulatory requirements, such as FDA 21 CFR Part 11, GAMP 5, and other relevant guidelines.
- Author, review, and approve validation documentation, including Validation Plans (VP), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct risk assessments to identify and mitigate potential risks related to computerized systems and data integrity.
- Collaborate with cross-functional teams, including Quality Assurance, IT, and Operations, to ensure systems meet user and regulatory requirements.
- Perform periodic reviews and revalidation of computerized systems to maintain compliance throughout their lifecycle.
- Troubleshoot and resolve CSV-related issues, ensuring minimal impact on production and operations.
Required Qualifications and Skills
- Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
- 3-5 years of experience in Computer System Validation (CSV) in the pharmaceutical, biotechnology, or medical device industry.
- In-depth knowledge of regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and data integrity guidelines.
- Proven experience with validation of various systems, including laboratory information management systems (LIMS), manufacturing execution systems (MES), and other enterprise systems.
- Strong technical writing skills with the ability to create, review, and approve detailed validation documentation.
- Excellent problem-solving skills and the ability to work independently as well as collaboratively in a team environment.
- Strong communication and interpersonal skills to interact effectively with cross-functional teams and stakeholders.
- Familiarity with quality management systems and good documentation practices (GDP).
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
