Engineer

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

Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, Solid works, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions

This may include, but is not limited to, the following:

• Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
• Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
• Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
• Developing, enhancing, automating, and managing test data
• Network with manufacturing and quality organizations internal to Client
• Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
• Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills

• Experience working in a regulated industry, exposure to GMPs
• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
• Statistical analysis, and knowledge of Gage R&R,
• Knowledge of Optical measurement devices, force testers, BLE testing
• Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

• Passion for proactively identifying opportunities through creative data analysis and modeling
• Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
• Ability to manage multiple, competing priorities simultaneously, experience with MS Project