Process Validation Engineer

We are hiring a Process Validation Engineer to support validation initiatives for sterile pharmaceutical manufacturing operations. This opportunity is ideal for professionals with experience driving validation activities for fill-finish processes while partnering with cross-functional teams to support manufacturing readiness and product lifecycle initiatives.

• Plan and execute process validation activities for sterile manufacturing operations.
• Lead qualification efforts to ensure manufacturing processes consistently meet quality and regulatory standards.
• Support validation of aseptic production processes and participate in manufacturing readiness activities.
• Work closely with Engineering, Manufacturing, Quality, and Technical Operations to implement new processes and improve existing ones.
• Contribute to technology transfer projects by supporting process implementation and documentation.
• Develop validation protocols, reports, and risk assessments while ensuring compliance with regulatory expectations.
• Assist with equipment and process requalification activities as part of ongoing manufacturing improvements.

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of pharmaceutical or biotech process validation experience.
• Hands-on experience supporting sterile manufacturing or fill-finish operations.
• Strong understanding of validation lifecycle, qualification activities, and cGMP regulations.
• Experience working on technology transfer or manufacturing scale-up projects is preferred.
• Exposure to Commissioning, Qualification & Validation (CQV) activities is a plus.
• Excellent communication and stakeholder management skills.