CQV Engineer

At PSC Biotech we are dedicated to ensuring that life sciences products are developed manufactured and distributed to the highest standards meeting all regulatory requirements and exceeding industry expectations. Our mission is to accelerate the success of our clients by providing essential services that support the creation of lifesaving products.

With a global presence spanning North America Europe Asia and the Middle East we take immense pride in the work we do and the talented professionals who contribute to our success. Join us in helping to shape the future of healthcare.

At PSC Biotech we bring together the brightest minds from across the globe to create a dynamic and inclusive work environment. Our multicultural teams are passionate about achieving excellence and innovation and we believe in the power of collaboration to drive success. When you join our team you ll not only be part of a company with a rich legacy of helping clients succeed but you ll also be given the opportunity to inspire and be inspired in your career.

We are committed to developing the next generation of leaders in the life sciences industry. Beyond competitive compensation and benefits we provide you with the resources training and mentorship to help you thrive and advance in your career.

At PSC Biotech we offer more than just a job it s an opportunity to build your future.

Your Role:

We are seeking motivated and experienced Commissioning Qualification Validation (CQV) Engineers at all levels (junior to senior). As a CQV Engineer you will play a critical role in ensuring the successful commissioning qualification and validation of equipment systems and processes within the pharmaceutical manufacturing industry. Your expertise will help ensure that our operations meet regulatory standards and industry best practices.

Key Responsibilities:

• Lead and support all CQV activities developing and executing comprehensive validation plans.
  
• Develop review and execute CQV protocols for a wide range of equipment facilities utilities systems and processes.
  
• Write review and approve technical CQV documentation including SOPs validation plans protocols risk assessments summary reports and design specifications.
  
• Conduct thorough risk assessments to identify potential validation risks and develop mitigation strategies.
  
• Manage investigations deviations and change control processes assessing the impact of changes on processes systems and equipment ensuring appropriate validation is conducted.
  
• Collaborate closely with crossfunctional teams including engineering manufacturing quality assurance and regulatory affairs to ensure alignment and seamless integration of CQV activities.
  
• Proactively recommend process improvements to ensure compliance with industry standards and best practices.
  
• Perform other duties as required to support the team and our clients success.
  

Requirements

• Bachelor s degree in Engineering (or a related field).
  
• Minimum of 3 years of handson experience in commissioning qualification and validation within the life sciences/pharmaceutical industry.
  
• Proven experience in executing CQV protocols for diverse equipment systems utilities and processes.
  
• Indepth knowledge of regulatory requirements and industry standards including cGMP GDP FDA EMA and more.
  
• Strong analytical problemsolving and troubleshooting skills with a keen attention to detail.
  
• Excellent communication skills and the ability to collaborate effectively with diverse teams.
  
• Ability to work both independently and in a fastpaced collaborative environment.
  
• Flexibility and willingness to travel as needed for client projects and assignments. The ability to adapt to different locations cultures and work environments is essential for successful team collaboration.
  

Preferred Qualifications:

• Aseptic Processing experience a plus.
  
• Aseptic Operations experience a plus.
  
• This position is projectbased through March 2026 with potential for extension or renewal.
  

Work Schedule:

• This position requires working from 8:00 PM to 5:00 AM Philippine time. Candidates must be comfortable with this schedule as it aligns with project and client needs.
  

Benefits