GMP-Test Methods Engineer & Data Innovator

ACL Digital; Cambridge (MA); On-site; USD 70,000 - 110,000; Full time

Job summary

ACL Digital is seeking a technically skilled professional to support senior staff in designing and delivering projects within the Physical Sciences and Engineering organization. The role involves development and lifecycle management of GMP test methods and automated testing platforms, translating user requirements into documentation, and performing engineering studies.

Ideal candidates have a background in statistics, CAD/SolidWorks, and lab experience, with exposure to regulated environments

Qualifications

• Bachelor's degree required; 3+ years of experience desired.
• Experience in regulated environments and GMP exposure preferred.
• Strong statistics background and data analysis skills.

Responsibilities

• Support senior staff in design and delivery of projects within PSE/Physical Sciences and Engineering.
• Develop and validate physical GMP test methods and lifecycle documentation (IQ/OQ, FAT/SAT).
• Assist with evaluation of automated test systems and data management.

Skills

Regulated industry experience

GMP exposure

Statistics fundamentals

Test method development

CAD design

SolidWorks

Mechanical modeling

R programming

Python

Lab experience

Education

Bachelor's degree

Tools

SolidWorks

Job description

ACL Digital is seeking a technically skilled professional to support senior staff in designing and delivering projects within the Physical Sciences and Engineering organization. The role involves development and lifecycle management of GMP test methods and automated testing platforms, translating user requirements into documentation, and performing engineering studies.

Ideal candidates have a background in statistics, CAD/SolidWorks, and lab experience, with exposure to regulated environments