Manufacturing Technician I - Medical Device
Overview
Manufacturing Technician I at Instylla owns primary packaging, formulation, filling, and final product shipment in an ISO Class 8 Cleanroom. You will support multiple product lines, from general packaging to formulation and filling, while following SOPs and GMP standards. This role sits within a small, agile team at a venture-backed medical device company in Bedford, MA, and offers hands-on experience with FDA-approved embolic systems.
What You'll Do8
- 1Execute primary packaging, formulation, and filling processes per SOPs and Work Instructions in an ISO Class 8 Cleanroom.
- 2Perform in-process inspections to verify product conformance to specifications and workmanship standards.
- 3Operate laboratory instruments such as balances, pH meters, and pipettes during formulation and testing.
- 4Handle materials in low dexterity environments including gloveboxes and fume hoods.
- 5Document manufacturing activities with clear, legible handwriting in batch records and logbooks.
- 6Follow current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) across all tasks.
- 7Coordinate with supervisor to prioritize changing demands and meet production deadlines.
- 8Maintain cleanroom integrity by wearing appropriate garments and following contamination control protocols.
Requirements10
- 11-3 years of manufacturing experience in Medical Device, Pharmaceutical, or Biotechnology.
- 2Proven ability to read and follow Work Instructions, process routers, and batch records.
- 3Working knowledge of cGMP and GDP in a manufacturing environment.
- 4Excellent hand/eye coordination with close vision, color vision, and fine detail magnification ability.
- 5Experience operating balances, pH meters, and pipettes.
- 6Strong attention to detail for executing procedures, performing inspections, and completing records.
- 7Self-motivated with organizational skills and the ability to work independently or in teams.
- 8Clear and legible handwriting for accurate documentation.
- 9Ability to stand or sit for up to 4 hours at a time and lift up to 50 pounds.
- 10Preferred: experience with gloveboxes, fume hoods, batch manufacturing, and handling liquid chemical formulations.
Salary Insight
$44 - $56k per year
Location
Required Skills
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