Manufacturing Specialist
Harba4 months ago
Indianapolis, IN, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Key Responsibilities
- Execute biopharmaceutical manufacturing processes with precision, ensuring compliance with cGMP regulations and industry standards.
- Operate, monitor, and troubleshoot production equipment to maintain efficient workflows and minimize downtime.
- Prepare, review, and maintain detailed manufacturing documentation, including batch records, SOPs, and deviation reports.
- Analyze and resolve equipment and process challenges, implementing corrective actions as needed.
- Collaborate closely with cross-functional teams such as Engineering, R&D, Quality Assurance, and Supply Chain to support seamless operations.
- Participate in the design, validation, and implementation of new manufacturing processes and equipment.
- Drive continuous improvement initiatives to enhance process efficiency, reduce waste, and maintain product quality.
- Ensure adherence to all safety protocols, maintaining a clean and organized work environment.
- Provide training and support to manufacturing staff to ensure compliance and knowledge of best practices.
Required Qualifications
- High school diploma or equivalent.
- 2+ years of experience in a regulated environment.
- Knowledge of GMP regulations and production equipment.
- Strong problem-solving, organizational, and communication skills.
- Ability to collaborate effectively with cross-functional teams.
- Detail-oriented with a focus on quality and compliance.
Required Skills
Documentation
Equipment Operation
Team Collaboration
Safety Compliance
cGMP compliance
Troubleshooting
Process Monitoring
Continuous Improvement