Manufacturing Associate
4 weeks ago
Shift: 12-Hour Night Shifts (7 PM - 7 AM)
Job Overview:
The Biotechnologist Associate is responsible for supporting the production of therapeutic proteins (Active Pharmaceutical Ingredients - API) in compliance with current Good Manufacturing Practices (cGMP). Working under close supervision, associates will learn and perform essential tasks, including operating equipment, monitoring production processes, and performing basic laboratory techniques. The role involves working in a clean room environment and following Standard Operating Procedures (SOPs) to ensure proper documentation, aseptic handling, and facility cleanliness.
Key Responsibilities:
- Execute Process Recipes: Follow written procedures and recipes for protein manufacturing.
- Equipment Monitoring: Set up, operate, and monitor production equipment for Clean-in-Place (CIP) and Steam-in-Place (SIP) processes.
- Laboratory Tasks: Conduct pH and conductivity measurements, perform sampling, and assist in routine sanitization tasks.
- Material Movement: Transfer raw materials and chemicals throughout production areas.
- Documentation: Complete required documentation in both written and electronic forms in adherence to cGMP and Good Documentation Practices (GDP).
- Clean Room Maintenance: Perform routine cleaning, sanitization of facilities, and equipment in support of 6S programs.
- Administrative Duties: Participate in shift exchanges, meetings, and projects, and handle email communications.
- Other Tasks: Perform any additional duties as assigned by management.
Qualifications:
- Educational Background: Scientific degree or related coursework preferred. Experience in manufacturing or a strong interest in the sciences is advantageous.
Key Skills:
- Ability to follow recipes and guidelines.
- Understanding of basic laboratory techniques (pH, sampling).
- Mechanical aptitude and problem-solving skills.
- Proficiency in computer skills, especially with automated systems.
- Strong attention to detail and ability to work in a regulated environment.
Additional Requirements:
- Must be comfortable working in a clean room environment and wearing gowning attire.
- Ensure that the provided telephone number is working, and voicemail is set up.
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