Computer System Validation Engineer
3 weeks ago
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring Computer Systems Validation Engineers. The CSV Engineer will support quality review, execute test scripts, and author and review CSV documentation and testing protocols. This role will support US PST timezone.
- Execute validation protocols and test scripts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems.
- Author and review validation documentation, including validation plans, protocols, and summary reports. Provide timely and accurate reports on validation status and findings to project stakeholders.
- Perform risk assessments to identify and mitigate potential system vulnerabilities.
- Provide detailed quality review.
- Evaluate and assess the impact of changes to computerized systems, ensuring that all modifications are validated appropriately.
- Ensure that computer systems adhere to regulatory guidelines.
- Collaborate with cross-functional teams.
- Additional responsibilities as required.
Requirements
- Bachelor's Degreein (or equivalent) in related discipline.
- 2+ years of computer system validation engineering experience in the life science industry.
- Experienced with CSV enterprise applications and instrumentation.
- Thorough understanding of validation tools and methodologies.
- Strong knowledge of regulatory requirements and guidelines
- Strong analytical and problem-solving skills, with attention to detail.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
#LI-FF1
Requirements
Bachelor's Degreein (or equivalent) in related discipline. 2+ years of computer system validation engineering experience in the life science industry. Experienced with CSV enterprise applications and instrumentation. Thorough understanding of validation tools and methodologies. Strong knowledge of regulatory requirements and guidelines Strong analytical and problem-solving skills, with attention to detail. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. #LI-FF1
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