Biotech and Pharmaceutical, Calibration, Cleanroom, Current Good Manufacturing Practice (cGMP), Equipment Maintenance/Repair, Equipment Specification, FDA Requirements, ISO (International Organization for Standardization), Identify Issues, Manufacturing, Manufacturing Equipment, Manufacturing Methods, Manufacturing Operations, Problem Solving Skills, Quality Metrics, Regulatory Requirements, Safety/Work Safety, Standard Operating Procedures (SOP), Testing, Time Management
Job Summary:
- Executes quality and manufacturing procedures to meet production demands and regulatory requirements.
- Ensures on-time production of pharmaceutical intermediates, semi-finished, and finished products meeting quality standards.
- Assists in setting up equipment operating specifications, SOPs, and improving manufacturing techniques.
- Supports equipment maintenance, calibration, and troubleshooting.
- Night Shift Hours: Alternating Wednesdays, plus every Thursday, Friday, and Saturday from 6:00 PM 6:30 AM.
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.
- Fully qualified to operate ~50% of manufacturing equipment.
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).
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Macpower Digital Assets Edge Private Limited