Sr. Aseptic/EMPQ Validation Engineer

Eliquent Life Sciences, Inc • Seattle, WA

10h

About The Position

The Sr. Aseptic/EMPQ Validation Engineer plays a critical role in ensuring that aseptic manufacturing processes and environmental monitoring programs meet stringent regulatory and quality standards. This position is responsible for designing, developing, and executing validation protocols that confirm the performance and reliability of manufacturing equipment and processes. The engineer will lead efforts to validate aseptic processing environments, ensuring contamination control and compliance with industry best practices. Collaboration with cross-functional teams including quality assurance, manufacturing, and engineering is essential to drive continuous improvement and maintain operational excellence. Ultimately, this role ensures that products are manufactured in a controlled environment that guarantees patient safety and product efficacy.

Requirements

• Bachelor’s degree in Engineering, Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in aseptic process validation and environmental monitoring within a regulated manufacturing environment.
• Strong knowledge of cGMP regulations, FDA guidelines, and aseptic processing standards.
• Proven experience in developing and executing validation protocols including IQ, OQ, and PQ.
• Excellent documentation and communication skills.
• Strong EMPQ experience; ideally experience with smoke studies

Nice To Haves

• Certification in validation or quality assurance (e.g., ASQ Certified Quality Engineer).
• Experience with automated environmental monitoring systems and data trending software.
• Familiarity with risk management and root cause analysis methodologies.
• Previous experience working in sterile pharmaceutical or biotechnology manufacturing.

Responsibilities

• Develop, review, and execute aseptic and EMPQ (Environmental Monitoring Program Qualification) validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Lead environmental monitoring activities and analyze data to assess the cleanliness and control of aseptic manufacturing areas.
• Collaborate with manufacturing, quality assurance, and engineering teams to identify validation requirements and implement corrective actions when deviations occur.
• Maintain comprehensive documentation and validation reports in compliance with cGMP, FDA, and other regulatory guidelines.
• Support audits and inspections by regulatory agencies by providing validation documentation and technical expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level