Manufacturing Operations Specialist
5 days ago
Fladger Assoc. Inc. is seeking a highly skilled Manufacturing Operations Specialist to join our team. As a key member of our production team, you will be responsible for operating and maintaining complex process equipment, ensuring compliance with current Good Manufacturing Practices (cGMPs), and providing training to colleagues.
Key Responsibilities- Equipment Operation and Maintenance
- Operate upstream, downstream, and central services processing equipment according to established Standard Operating Procedures (SOPs).
- Maintain equipment in good working condition, performing routine maintenance and troubleshooting as needed.
- Production Support
- Support production operations by following established manufacturing production records (MPRs and SPRs) and adhering to cGMP standards.
- Collaborate with cross-functional teams to ensure smooth production processes.
- Training and Development
- Provide training to colleagues on equipment operation and maintenance.
- Develop and maintain documentation related to equipment operation and maintenance.
- Quality Assurance
- Ensure compliance with cGMP standards and regulatory requirements.
- Participate in quality audits and investigations as needed.
- Education and Experience
- Bachelor's Degree in a relevant field (e.g., engineering, biology, chemistry) or equivalent experience.
- 0-2 years of experience in a manufacturing or bioprocessing environment.
- Skills and Qualifications
- Advanced knowledge of cGMP standards and regulatory requirements.
- Excellent problem-solving and analytical skills.
- Ability to work independently and as part of a team.
- Strong communication and training skills.
The selected candidate will work a 2-2-3 schedule, with 2 days on, 2 days off, and 3 days on, rotating shifts including nights.
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