CSV Engineer
CSV Engineer
Posted on :
10-04-2025
Employer Active
1 Vacancy
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Jobs by Experience
5-7years
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
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 multicultural 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 seeking a highly skilled CSV Engineer with strong experience in Part 11 compliance to join our team. As a CSV Engineer you will be responsible for ensuring that our computer systems software and equipment comply with regulatory requirements with a particular focus on 21 CFR Part 11 which governs electronic records and signatures. You will play a critical role in validating and qualifying systems to ensure they meet industry standards and remain in compliance with relevant regulations.
Responsibilities
- Ensure compliance with 21 CFR Part 11 and other regulatory standards (e.g. GxP FDA EMA).
- Execute Validation Protocols such as IQ OQ and PQs to ensure compliance and adherence with applicable guidelines.
- Review and modify Standard Operating Procedures (SOPs).
- Develop review and execute validation protocols and reports ensuring the accurate and thorough validation of computer systems throughout their lifecycle.
- Write risks assessments and applicable test scripts according to GLP & 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
- Maintain uptodate knowledge of industry regulations standards and guidelines specifically those related to Part 11.
- Prepare validation summary reports for executed protocols.
- Troubleshoot and resolve issues related to validated systems working closely with internal teams to implement corrective actions.
Requirements
- Bachelors degree in Computer Science Engineering Life Sciences or a related field.
- 58 years of experience in Computer System Validation (CSV) with a strong understanding of 21 CFR Part 11 regulations.
- Indepth knowledge of industry standards and guidelines related to CSV including GxP FDA and other regulatory requirements.
- Strong analytical skills with the ability to think critically and solve problems effectively.
- Excellent written and verbal communication skills with experience in creating validation documentation.
- Leadership experience is a plus.
- Interested in making a contribution to the company while learning.
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
Medical Dental and Vision PSC pays 100 of all qualifying employee medical premiums and 50 for qualifying dependents
Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO Sick Time and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more).
Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age 40 or older) disability genetic information or any other status protected by law.
#LIJD1
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field. 5-8 years of experience in Computer System Validation (CSV), with a strong understanding of 21 CFR Part 11 regulations. In-depth knowledge of industry standards and guidelines related to CSV, including GxP, FDA, and other regulatory requirements. Strong analytical skills with the ability to think critically and solve problems effectively. Excellent written and verbal communication skills, with experience in creating validation documentation. Leadership experience is a plus. Interested in making a contribution to the company while learning.
Employment Type
Full Time
Key Skills
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