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), and Manufacturing Science activities.

Key Responsibilities:

• Lead or support deviations and investigations related to drug product manufacturing
• Serve as process owner for designated unit operations or systems
• Author and review SOPs, validation protocols, and technical reports
• Perform data analysis to support process understanding, validation, and transfer
• Contribute to the preparation and review of content for regulatory filings
• Collaborate with cross-functional teams including QA, Regulatory Affairs, Eng and Eng services, and Operations

• Strong knowledge of process validation principles and lifecycle approach (PPQ, continued process verification)
• Experience supporting or leading tech transfer projects in a GMP environment
• Demonstrated proficiency in investigation writing, CAPA, and change control systems
• Hands-on experience with SOP, protocol, and report authorship
• Ability to analyze and interpret manufacturing and analytical data
• Familiarity with regulatory submission content and expectations (e.g., Module 3, 3.2.P.3, etc.)
• Excellent communication, collaboration, and project management skills
• Experience in biologics or sterile injectable drug product manufacturing is preferred

Salary Range: 115k-130k

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.