Now Hiring: Senior Validation Engineer – Advance Innovation in Life-Saving Pharmaceuticals
Location: Onsite – Indianapolis, IN | Pay: $42.97 – $71.42/hr
Schedule: 1st Shift, Flexible to support extended hours or second shift when needed to ensure the project's critical timeline is maintained.

PDS Tech Commercial is looking for a highly motivated and experienced Senior Validation Engineer to support a leading-edge pharmaceutical manufacturing environment in Indianapolis, IN. This role is a unique opportunity to apply your expertise in engineering and validation to ensure the delivery of high-quality, safe, and compliant products that make a difference in patients’ lives.

About the Role

As a Senior Validation Engineer, you will be responsible for the full lifecycle of Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, and manufacturing equipment. You will drive compliance, troubleshoot complex systems, and lead initiatives that strengthen the performance and reliability of critical operations. Your contributions will directly impact the success of large-scale production and the ongoing delivery of essential therapies.

Key Responsibilities

• Lead the planning and execution of CQV activities for manufacturing and facility systems

• Review and approve validation protocols (DQ, IQ, OQ, PQ) and ensure alignment with GMP standards

• Perform risk assessments, including GMP and sensor-based evaluations

• Troubleshoot process and equipment issues during startup, PQ, and validation

• Support the setup of maintenance plans, spare parts inventory, and technical documentation

• Maintain and manage master equipment and instrument inventories (MEI/MII)

• Lead investigations, change assessments, and root cause analyses related to equipment and system deviations

• Support internal and external audits and ensure data integrity across all documentation systems

• Interpret and update P&IDs, wiring diagrams, control systems, and technical drawings

• Collaborate across departments to drive technical projects and continuous improvement efforts

• Provide second-line escalation support for equipment and reliability issues

• Utilize automation systems (SCADA/PLCs) to gather data and optimize performance

Qualifications

Required:

• Bachelor’s degree in Engineering or a related technical field

• 5+ years of validation or engineering experience in a GMP-regulated pharmaceutical manufacturing environment

• Strong understanding of commissioning, qualification, and validation methodologies

• Familiarity with aseptic filling processes and regulatory compliance standards

• Excellent troubleshooting, documentation, and project coordination skills

Preferred:

• Hands-on experience with aseptic pharmaceutical equipment

• Vendor management or contractor oversight experience

• Proficiency with CMMS systems and automation technologies

Why Join Us?

When you join PDS Tech Commercial, you become part of a team that partners with world-class innovators in the pharmaceutical industry. You’ll work on impactful projects in a highly collaborative environment where your expertise is valued and your contributions are recognized. This is more than a job—it’s a chance to build a career in an industry that improves and saves lives every day.

Enjoy competitive compensation, a structured first-shift schedule, and the satisfaction of doing work that truly matters.

Take the Next Step in Your Engineering Career

If you're a seasoned validation expert ready to lead challenging, high-impact projects, we want to hear from you. Apply now and help shape the future of pharmaceutical manufacturing excellence.

PDS Tech Commercial – Where Expertise Meets Opportunity.

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