What are the responsibilities and job description for the Sr. Aseptic/EMPQ Validation Engineer position at Eliquent Life Sciences, Inc?
About Company:
Who Are We?
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
Why explore your future at ELIQUENT?
ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
About the Role:
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.
Minimum Qualifications:
- 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
Preferred Qualifications:
- 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.
Skills:
The required skills such as protocol development and validation protocols are applied daily to design and implement robust validation strategies that ensure aseptic processes meet regulatory standards. Performance validation skills are critical for assessing equipment and process capabilities to maintain product quality and safety. Environmental monitoring expertise is used to continuously evaluate the manufacturing environment, identify potential contamination risks, and implement corrective actions. Preferred skills like risk management and data analysis enhance the ability to proactively address issues and optimize validation processes. Strong communication and documentation skills ensure clear reporting and effective collaboration across multidisciplinary teams.
Salary : $110,000 - $140,000