CQV 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 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 a Commissioning Qualification Validation Engineer. The Engineer will support the development of utilities documentation. Successful candidates will be experienced in writing IQ PQ PQ and traceability matrix documentation and protocols with knowledge of utility equipment such as HVAC CDA vacuums specialty gasses RO water and UPS. This is a remote position.

• Create review and update validation documentation for utilities systems including but not limited to HVAC CDA vacuums specialty gasses RO water and UPS.
  
• Ensure that all documentation is in compliance with industry regulations company standards and best practices.
  
• Provide technical support during the execution of validation activities troubleshooting issues as they arise.
  
• Investigate and document deviations from established procedures working closely with relevant teams to implement corrective actions.
  
• Participate in project meetings and communicate effectively with stakeholders to drive documentationrelated activities.
  
• Identify opportunities for process improvement in validation documentation practices.
  
• Additional responsibilities as required.
  

Requirements

• Bachelors Degree in Engineering or related.
  
• 24 years of experience developing utilities validation documentation.
  
• Proven experience in utilities validation within a regulated industry (pharmaceuticals biotechnology etc.).
  
• Excellent technical writing skills.
  
• Utilities experience in the following equipment/systems: HVAC CDA vacuums specialty gasses RO water and UPS.
• Strong understanding of validation principles GMP and regulatory requirements (FDA EMA etc.).
  
• Excellent documentation skills with a keen attention to detail.
  
• Effective communication and collaboration skills.
  

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.

#LIFF1

Bachelor's Degree in Engineering or related. 2-4 years of experience developing utilities validation documentation. Proven experience in utilities validation within a regulated industry (pharmaceuticals, biotechnology, etc.). Excellent technical writing skills. Utilities experience in the following equipment/systems: HVAC, CDA, vacuums, specialty gasses, RO water, and UPS. Strong understanding of validation principles, GMP, and regulatory requirements (FDA, EMA, etc.). Excellent documentation skills with a keen attention to detail. Effective communication and collaboration skills. 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. #LI-FF1