MSAT Engineer

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

The MSAT Engineer will support the Existing Commercial Product Improvement Project as a Subject Matter Expert (SME), with responsibilities spanning Process Validation, Technology Transfer (TT), Manufacturing Science, and process/technology development activities. This role will also involve significant support for purification and fractionation processes, including filtration technologies and upstream operations.

Key Responsibilities

• Lead or support deviations, investigations, and CAPA activities related to drug product manufacturing.
• Serve as process owner for designated unit operations or systems, including purification, upstream processing, and plasma-derived product fractionation steps.
• Support and provide SME input for filtration operations—particularly filter press systems—and related unit operations involving buffers, vessels, and UF/DF or TFF skids.
• Perform data analysis to support process understanding, validation, technology transfer, and DOE (Design of Experiments) studies.
• Author, review, and manage technical documentation including SOPs, batch records, validation protocols, and technical reports.
• Conduct non-GMP laboratory development work, including sample testing, data analysis, and method evaluation to support process characterization and optimization prior to GMP execution.
• Collaborate as a liaison between development labs, manufacturing operations, QA, Regulatory Affairs, Engineering, and other cross-functional teams.
• Prepare technical slide decks, data summaries, and presentation materials for internal reviews and external regulatory interactions, including meetings with the FDA.
• Contribute to the preparation and review of regulatory submissions (e.g., Module 3, 3.2.P.3).
• Participate in technology transfer activities to ensure smooth transition from development to GMP operations.

Requirements

• Strong knowledge of process validation principles and the PV lifecycle (PPQ, continued process verification).
• Experience supporting or leading technology transfer projects in a GMP environment.
• Demonstrated proficiency in deviation and investigation writing, CAPA, and change control management.
• Hands-on experience authoring SOPs, protocols, reports, and other technical documentation.
• Ability to analyze and interpret manufacturing, analytical, and development data.
• Experience with purification processes, upstream operations, plasma fractionation, filtration (including filter press systems), buffer preparation, and UF/DF or TFF skids preferred.
• Familiarity with regulatory expectations for submissions and dossier content.
• Strong communication, collaboration, and presentation skills, including ability to prepare and present data to regulatory agencies.
• Experience working in biologics, sterile injectables, or plasma-derived product manufacturing is highly preferred.
• Ability to work in both development (non-GMP) and GMP environments as processes advance through the lifecycle.

Benefits

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.