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 are hiring a QA Validation Engineer. This role is critical in ensuring that all equipment, systems, and processes used in pharmaceutical manufacturing validation activities meet regulatory requirements and industry standards. The ideal candidate will have a strong background in validation protocols, GMP compliance, and risk-based approaches to quality assurance.

• Provide quality assurance oversight to validation, engineering, and manufacturing, ensuring compliance with regulatory requirements (FDA, CGMP, GDP).
• Maintain and update validation documentation in accordance with internal SOPs and regulatory expectation,
• Review and approve technical documentation including but not limited to IQ, OQ, PQ protocols, requirement specifications, risk assessments, and standard operating procedures.
• Support investigations and CAPAs related to validation deviations or failures.
• Perform risk assessments and gap analyses to identify areas of improvement in validation processes and documentation.
• Collaborate with cross-functional teams including Engineering, Manufacturing, and Quality Control to support validation activities.
• Participate in audits and inspections, providing validation documentation and expertise.
• Stay current with industry trends and regulatory changes impacting validation and documentation practices.
• Additional responsibilities as required.
  
  

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 7 years of proven experience in validation within the pharmaceutical industry.
• Advanced understanding of full validation lifecycle documentation coupled with excellent technical writing skills.
• Strong knowledge of regulatory requirements and industry guidelines (FDA, CGMP, GDP, etc.)
• Excellent analytical and technical problem solving skills.
• Effective communication and interpersonal skills.
• Proactive with strong organization, time management, and project management abilities.
• 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.
  
  

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts
  
  

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 - $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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.