MSAT Engineer

New Yesterday

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 Requirements 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 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.
Location:
Thousand Oaks
Job Type:
PartTime

We found some similar jobs based on your search