Manufacturing Associate
Vor 4 Tagen
**Job Summary**:
Perform and document daily manufacturing operations in a cGMP environment, including operating process equipment, executing validation protocols, and revising cGMP documentation. Ensure compliance with cGMP standards while maintaining equipment and facilities. This role requires strong attention to detail and expertise in automated systems and process controls. Additionally, provide support to other functions on site and maintain training to the required level.
**Principal Accountabilities**:
- Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation (65%).
- Perform troubleshooting/investigation of equipment and process issues (10%).
- Revise documents as instructed, capable of equipment and/or process changes (5%).
- Actively participate in training activities, managing your individual training plan. Train other associates as required (5%).
- Execute validation protocols (5%).
- Capable of leading shifts when the supervisor is absent and actively lead or participate in shift exchanges. Coordinate activities and daily schedules with cross-functional areas (5%).
- Perform other job duties assigned from time to time (5%).
**Minimum Education Requirements**:
Relevant education from the chemical industry, food industry, pharmaceutical, or biotech industry.
**Minimum Experience Requirements**:
- High school diploma or equivalent experience and typically 9-11 years relevant experience in Pharma/Biotech industry OR
- Bachelor's degree in a related field with 5-6 years Pharma/Biotech professional experience OR
- Bachelor's degree in an unrelated field and typically 7-9 Pharma/Biotech years’ experience.
- Good understanding of Delta V or Syncade or similar automated systems.
- Understanding of full Biotech process.
- Languages: English B1, German and/or French are assets.
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