Senior QA Validation 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 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're hiring a Senior QA Validation Engineer, responsible for leading and executing validation activities to ensure compliance with cGMP, FDA, EMA, ICH, and other regulatory requirements. The ideal candidate will have extensive experience in equipment validation, aseptic facilities, and clean room processes, within a regulated pharmaceutical setting.

• Ensure validation activities are conducted in compliance with regulatory requirements and internal quality standards.
  


• Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues.
  


• Develop and execute commissioning, qualification, and validation protocols for required equipment and systems, including but not limited to aseptic facilities validation, clean room facilities, laboratory equipment and utilities.
  


• Devevlop, review, and author master plans, summary reports, final reports, requirements and specifications, etc. ensuring quality and regulatory compliance.
  


• Identify and assess risks associated with validation activities and develop mitigation strategies. Investigate and resolve validation deviations and non-conformances.
  


• Troubleshoot and resolve issues related to equipment and process performance.
  


• Additional responsibilities as required.

Requirements

• Bachelor’s degree in engineering or a related field.
  


• 10+ years of quality assurance experience with focus on validation within pharmaceutical manufacturing industries.
  


• Advanced knowledge of regulatory requirements.
  


• Experienced with laboratory equipment, aseptic facilities, cleanrooms, and critical utilities.
  


• Proven success in leading QA Validation projects.
  


• Expertise in validation lifecycle management and risk-based approaches.
  


• Excellent analytical and technical problem-solving skills. Ability to analyze project risks effectively and implement resolutions.
  


• Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
  


• Effective communication and interpersonal skills. Ability to manage stakeholder communication and cross-functional team collaboration.
  


• Proactive with strong organization and time management skills.
  


• Excellent attention to detail with commitment to quality and compliance.
  


• Travel is required. 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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