Manufacturing Operator
MDAEdge · Danbury, CT · 1 mo ago
On-siteOTHRFull-time
Key Responsibilities
- Performs semi-routine tasks requiring judgment in problem-solving and recommendations.
- May guide lower-level personnel on assignments.
- Executes manufacturing operations per Manufacturing Records, cGMP, and SOPs in a cleanroom environment.
- Sets up, cleans, and sanitizes manufacturing areas and equipment under supervision.
- Operates production equipment per Manufacturing Records and SOPs (with supervision).
- Conducts in-process inspections and testing (with supervision).
- Accurately documents manufacturing activities in records, forms, labels, and logbooks.
- Verifies and confirms manufacturing steps performed by others.
- Follows all company health, safety, and environmental guidelines.
Minimum Qualifications
- High School/GED + 3-5 years of related experience (or equivalent training).
- Must pass medical clearance to wear a respirator (PAPR) for full shifts.
- Must be able to gown/de-gown in 3 layers of cleanroom attire (Tyvek® jumpsuit).
- Must comply with regulatory standards (FDA, ISO 13485, etc.).
Required Skills & Certifications
- 12-hour shift availability.
- 20% Shift Differential.
- Experience in production/manufacturing.
- Comfortable wearing Tyvek suit & respirator.
Schedule
- 3 days one week, 4 days the next (with OT on 4-day weeks).
Night Shift Hours
Alternating Wednesdays, plus every Thursday, Friday, and Saturday from 6:00 PM – 6:30 AM.
Pay
20% Shift Differential.
Schedule
3 days one week, 4 days the next (with OT on 4-day weeks).