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 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 an experienced Computer Systems Validation Engineer. The CSV Engineer will play a critical role in ensuring that all systems are validated and compliant with regulatory standards. This role involves planning, writing, implementing, and executing CSV protocols to ensure that our systems operate as intended and meet all regulatory requirements.

• Collaborate with project stakeholders and cross functional team to define project requirements. 
• Perform execution of CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT).
• Generate and execute validation documents and ensure compliance with required GxP and 21 CFR Part 11 regulations.
• Participate in the planning, development, and implementation of computer systems validation documentation.
• Manage and validate protocols, electronic records, and electronic signatures ensuring data integrity and compliance. Support data and system transfers as needed. 
• Ensure seamless integration of equipment as required. 
• Initiate and oversee system CSV associated change control requests and associated validation documentation.
• Author, review, and approve scheduled periodic reviews.
• Troubleshoot and resolve issues related to validated systems, working closely with internal teams to implement corrective actions.
• Additional responsibilities as assigned to drive project success. 

Requirements

• Bachelor's degree in Engineering, Computer Science, or a related field.
  
• 3-5 years of computerized system validation experience within the life sciences/pharmaceutical industries. 
  
• Strong knowledge of validation of cGxP computerized systems within FDA regulated environments.
  
• Strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, etc. 
  
• Proficiency in data integrity testing and compliance with FDA 21 CFR Part 11 regulations.
  
• Experience with equipment and system integration. 
  
• Strong analytical skills with the ability to think critically and solve problems effectively.
  
• Excellent written and verbal communication skills. 
  
• Strong time management and organizational abilities.
  
• Detail-oriented mindset with a commitment to maintaining high-quality standards.
  
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
  

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 employer-sponsored 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.

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