Manufacturing Technician

RevBio, Inc.•Lowell, MA

29d•$28 - $33•Onsite

About The Position

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.

Requirements

High school diploma or equivalent required
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
Ability to work within ERP and eQMS systems as instructed
Current knowledge of, or ability to quickly learn, cGMP regulations and applicable industry standards (e.g., FDA 21 CFR Part 820, ISO 13485)
Ability to identify and escalate 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
Willingness to support preventative and corrective maintenance activities on manufacturing equipment

Nice To Haves

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
Experience operating manufacturing or laboratory equipment in a regulated environment is desired

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
Perform other manufacturing-related tasks as assigned