Overview
Quality Engineer Jobs in Grand Island, NY at Beacon Hill
Title: Quality Engineer
Company: Beacon Hill
Location: Grand Island, NY
Position Summary:
This role supports documentation management, data collection, and equipment validation activities within a GMP-regulated pharmaceutical manufacturing environment. Responsibilities include preparing and maintaining qualification records, supporting validation studies, assembling and calibrating thermocouples, collecting analytical data, and assisting with system updates. The position requires excellent communication skills and a strong commitment to cGMP compliance.
Key Responsibilities:
Collect and organize equipment documentation, identify gaps, and collaborate with Validation Engineers and Quality Assurance to implement improvements.
Draft, update, and file qualification and validation documents in accordance with cGMP and internal procedures.
Assist in executing equipment validation studies, including protocol execution, data analysis, and support for control system administration (e.g., backups and software updates).
Operate and program analytical instruments (e.g., temperature/humidity data loggers) to perform qualifications on controlled environments such as lyophilizers, warehouses, sterilizers, and incubators.
Draft commissioning and qualification protocols that demonstrate equipment is designed and fit for intended use.
Participate in system requalification and continuous improvement efforts in accordance with change management procedures.
Maintain compliance with regulatory guidelines and internal standards.
Qualifications:
Bachelor’s degree in Science, Engineering, Manufacturing Technology, or a related field; or equivalent hands-on experience in a regulated manufacturing environment.
0–2 years of experience in pharmaceutical manufacturing or a similar GMP-regulated industry.
Strong organizational and documentation skills, with a working knowledge of cGMP principles.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office tools (Word, Excel, etc.).
Basic mechanical aptitude preferred.
Familiarity with statistical tools or analytical methods is a plus.
