GMP Test Methods & Automation Engineer

Crystal Equation Corporation; Cambridge (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Crystal Equation Corporation seeks a qualified engineer to support senior staff in initiating, designing, and delivering projects within the Combination Product Operations MS&T - PSE organization. The role develops Physical GMP Test Methods and manages equipment lifecycle while translating user needs into technical documentation.

Responsibilities include assisting with automated test systems, performing engineering studies, and evaluating new technologies to improve data-driven decisions.

Qualifications

• Experience in a regulated industry with GMP exposure.
• Excellent verbal and written communication to report status and risks.
• Statistical analysis and knowledge of Gage R&R.
• Knowledge of optical measurement devices and force testers.
• Manufacturing experience with IQ, OQ, and PQ.

Responsibilities

• Collaborate with Engineers to edit, develop, and run automated protocols.
• Knowledge on validation principles and generation of lifecycle documentation (FAT/SAT, IQ/OQ).
• Assist with development, transfer and execution of processes on integrated platforms and equipment.
• Develop, enhance, automate, and manage test data.
• Network with manufacturing and quality organizations.
• Ensure tasks and responsibilities are documented per SOPs.

Skills

GMP exposure

Statistical analysis

Documentation skills

Communication skills

Manufacturing experience

Tools

MS Project

IQ/OQ

FAT/SAT

Gage R&R

Job description

Crystal Equation Corporation seeks a qualified engineer to support senior staff in initiating, designing, and delivering projects within the Combination Product Operations MS&T - PSE organization. The role develops Physical GMP Test Methods and manages equipment lifecycle while translating user needs into technical documentation.

Responsibilities include assisting with automated test systems, performing engineering studies, and evaluating new technologies to improve data-driven decisions.