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Validation Engineer
Validation EngineerPSC Biotech • Denver, CO, US
Validation Engineer

Validation Engineer

PSC Biotech • Denver, CO, US
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Job Description

Job Description

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 an experienced Validation Engineer to support equipment, process, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP and regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.

  • Perform validation of PLC logic and operational sequences across normal, abnormal, and emergency scenarios.
  • Conduct end‑to‑end testing of SCADA system integrations, ensuring accurate process visualization, trending, and operator control functionality.
  • Execute real‑time testing of sitewide system interactions, including signal communication between PLCs, SCADA platforms, and auxiliary equipment.
  • Verify data logging capabilities and integration with the PI Historian to support batch reporting, audit trails, and regulatory compliance documentation.
  • Assess network resilience by testing system redundancy, communication failover, and implementation of security and access‑control protocols.
  • Ensure seamless integration and validation of manufacturing equipment and facility systems.
  • Troubleshoot and resolve issues related to validated equipment and processes, implementing corrective and preventive actions (CAPA) as needed.
  • Additional responsibilities as assigned to drive project success.

Requirements

  • Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences
  • 2–5 years of validation experience within the pharmaceutical, biotech, or medical device industries
  • Strong knowledge of equipment and process validation in FDA-regulated environments
  • Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations
  • Experience with cleanroom systems, HVAC, purified water, compressed air, and other critical utilities
  • Proficiency in writing and executing IQ / OQ / PQ protocols and validation reports
  • Strong analytical and problem-solving skills
  • Excellent written and verbal communication abilities
  • Strong time management and organizational skills
  • Detail-oriented mindset with a commitment to maintaining high-quality standards
  • Must be authorized to work in the US
  • No C2C at this time
  • Benefits

    W2 positions include our medical and sick time benefits.

    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-RW1

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