CSV Engineer

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 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

• Develop and execute validation plans and protocols for required computerized systems including but not limited to IQ OQ PQ.
  
• Perform required testing activities including system verification and validation qualification risk assessments and so on.
  
• Develop user requirements required test scripts and traceability matrices.
  
• Provide quality review of required documentation and system implementation processes.
  
• Maintain review and author required validation documentation ensuring compliance with industry standards and regulatory requirements.
  
• Initiate and oversee system associated change control requests.
  
• Author review and or approve scheduled periodic reviews.
  
• Effectively identify potential risks and implement mitigation strategies.
  
• Collaborate with crossfunctional teams to ensure alignment on deliverables and successful project completion.
  
• Additional responsibilities as required.
  

Requirements

• Bachelor s degree in related engineering discipline.
  
• 25 years of direct computer system validation execution experience within the pharmaceutical and/or biotech industries.
  
• Experience in Argus system is required.
  
• Proven success in providing QA review for required validation lifecycle documentation.
  
• Experienced developing validation protocols plans user requirements and test scripts.
  
• Strong understanding of regulatory requirements (FDA 21 CFR Part 11 GAMP5 etc.).
  
• Excellent analytical and problemsolving skills.
  
• Strong communication skills both verbal and written.
  

Benefits

Estimated pay (based on experience): $50/hr. $60/hr.

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.