Equipment 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 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 motivated and hands-on engineers with direct experience in commissioning, qualifying, and validating pharmaceutical manufacturing facilities, utilities, and large-scale process equipment. This role is critical to ensuring the successful startup and compliance of complex systems used in regulated environments. You will be responsible for developing and executing validation protocols, troubleshooting equipment, and generating comprehensive lifecycle documentation.

• Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ) for cleanroom environments and large process equipment.
• Write and review technical documentation including specifications (URS, FS, DS), SOPs, risk assessments, and final reports.
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations.
• Conduct impact, gap, and risk assessments to identify potential issues and implement mitigation strategies.
• Analyze test data and acceptance criteria to ensure accuracy and compliance.
• Operate and troubleshoot equipment during startup and validation phases to assess performance and recommend modifications.
• Ensure all validation activities meet current industry standards and regulatory requirements (cGMP, FDA, etc.).
• Additional responsibilities as needed to support project deliverables.

Requirements

• Bachelor's degree in Engineering or a related technical field.
• 2 – 7 years of hands-on experience commissioning, qualifying, and validating process equipment within the pharmaceutical manufacturing industry.
• Experience qualifying cleanroom facilities.
• Experience in large process equipment in pharmaceutical manufacturing (vessels, centrifuges, filter presses and CIP skids).
• Experienced writing and generating technical validation documentation including final summary reports, IQOQPQ protocols, specifications (URS, FS, DS), operating procedures, etc.
• Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.).
• Strong understanding of risk-based validation approach.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects and work both independently and collaboratively.
• Ability to work extended hours
• 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.
• Must be authorized to work in the US.
• No C2C at this time.

Benefits
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $100,000 annually. The salary offered 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.**