Manufacturing Technician

RevBio, Inc.; Lowell (MA); Presencial; USD 42 000 - 66 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Dental insurance

Employee discounts

Health insurance

Paid time off

Vision insurance

Resumo da oferta

RevBio, Inc. in Lowell, MA, seeks a Manufacturing Technician to perform hands-on manufacturing, assembly, and production of Tetranite-based medical devices, following SOPs and work instructions.

You will support all stages of production, including material staging, equipment setup, in-process inspection, and real-time documentation in ERP and eQMS. The role emphasizes GDP, batch records, DHRs, calibration, and maintenance, with collaboration across QA, R&D, and cross-functional teams to drive

Qualificações

• High school diploma or equivalent required.
• Associate's degree, technical/trade certificate, or manufacturing experience preferred.
• Minimum one year of manufacturing or production experience in FDA-regulated or ISO 13485 environment preferred.

Responsabilidades

• Manufacture Tetranite-based products through all stages of production using SOPs and work instructions.
• Set up, operate, and maintain manufacturing equipment per approved procedures.
• Manage and maintain inventory of raw materials, WIP and finished goods per SOPs.
• Perform in-process inspections and provide test documentation.
• Complete batch records and device history records (DHRs) in real time per GDP.
• Identify, document, and report manufacturing nonconformances and deviations to management and quality.
• Perform routine calibrations and preventive/corrective maintenance on equipment.
• Support manufacturing process improvements and process validation activities.
• Maintain a clean, organized, and compliant work area per cGMP and GDP.
• Participate in internal, external, and regulatory audits and inspections.
• Assist in packaging, staging, and shipment of materials and finished products, including inventory tracking.
• Maintain updated training records to SOPs per QMS.
• Perform other manufacturing-related tasks as assigned.

Conhecimentos

SOP literacy

Manual dexterity

GDP knowledge

MS Excel

ERP/eQMS usage

Formação académica

High school diploma

Associate degree preferred

Ferramentas

ERP

eQMS

Descrição da oferta de emprego

Benefits:

• Dental insurance
• Employee discounts
• Health insurance
• Paid time off
• Vision insurance

The Manufacturing Technician will be responsible for performing hands‑on manufacturing, assembly, and production activities for Tetranite‑based medical device products in accordance with company-approved work instructions and standard operating procedures (SOPs). The Manufacturing Technician will support all stages of production, including material staging, equipment set‑up and operation, in‑process inspection, and finished product handling. This individual will also assist with maintaining production records using good documentation practices within the company's enterprise resource planning (ERP) and electronic quality management system (eQMS), including documenting nonconformances, and supporting continuous improvement and preventative/corrective maintenance activities on manufacturing equipment.

Essential Duties & Responsibilities

• Manufacture Tetranite-based products through all stages of production using company-issued work instructions and SOPs;
• Set up, operate, and maintain manufacturing equipment in accordance with approved procedures;
• Manage and maintain inventory of raw material supplies as well as WIP and finished goods parts for manufacturing per SOPs;
• Perform in-process inspections and provide associated test documentation;
• Accurately complete batch records, device history records (DHRs), and other manufacturing documentation in real time per Good Documentation Practices (GDP);
• Identify, document, and report manufacturing nonconformances and deviations to management and quality in a timely manner;
• Perform routine calibrations, preventative maintenance (PM) and basic corrective maintenance (CM) on manufacturing equipment;
• Support manufacturing process improvements and process validation activities;
• Maintain a clean, organized, and compliant work area in accordance with cGMP and Good Documentation Practices (GDP);
• Participate in internal, external, and regulatory Agency audits and inspections;
• Assist in the packaging, staging, and shipment of materials and finished products, including inventory tracking;
• Maintain updated training records to SOPs per QMS; and
• Perform other manufacturing-related tasks as assigned.

Essential Education, Skills, Environment Education and Work Experience

• High school diploma or equivalent required; Associate's degree, technical/trade school certificate, or relevant manufacturing experience preferred;
• Minimum one year of manufacturing or production experience, preferably within an FDA-regulated or ISO 13485-certified medical device company;
• Working knowledge of MS Word and MS Excel;
• Ability to read and follow detailed work instructions, SOPs, and batch records with a high degree of accuracy;
• Demonstrated attention to detail and good manual dexterity for hands‑on assembly and inspection tasks;
• Ability to work on a standard on‑site workday schedule, including cleanroom or controlled manufacturing environments as required; and
• Ability to work within ERP and eQMS systems as instructed.

Specialized Knowledge and Skills

• Current knowledge of, or ability to quickly learn, cGMP regulations and applicable industry standards (e.g., FDA 21 CFR Part 820, ISO 13485);
• Experience operating manufacturing or laboratory equipment in a regulated environment is desired;
• Ability to identify and elevate product or process nonconformances;
• Strong verbal and written communication skills for documenting manufacturing activities per GDP and reporting issues;
• Ability to work both independently and collaboratively within a cross‑functional team which includes manufacturing, R&D and quality; and
• Willingness to support preventative and corrective maintenance activities on manufacturing equipment.