Engineer

Crystal Equation Corporation; Cambridge (MA); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP exposure

Statistical analysis

Documentation skills

Communication skills

Manufacturing experience

Outils

MS Project

IQ/OQ

FAT/SAT

Gage R&R

Description du poste

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

Responsibilities

• 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
• 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

Required 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 Skills

• 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