Manufacturing Specialist

Harba; Indianapolis (IN); On-site; USD 40,000 - 60,000; Full time

Job summary

Harba is seeking a skilled manufacturing associate in Indianapolis, IN, to execute biopharmaceutical manufacturing processes in compliance with cGMP regulations. Ideal candidates will have at least 2 years of experience in a regulated environment, a strong understanding of GMP, and the ability to collaborate effectively with various teams.

You will perform essential duties such as troubleshooting production equipment, maintaining manufacturing documentation, and driving continuous improvements in processes. A high school diploma or equivalent is required.

Qualifications

• Minimum of 2 years of experience in a regulated environment.
• Ability to operate production equipment and troubleshoot issues.
• Effective collaboration with cross-functional teams.

Responsibilities

• Execute biopharmaceutical manufacturing processes ensuring compliance.
• Monitor and troubleshoot production equipment to minimize downtime.
• Prepare and maintain detailed manufacturing documentation.
• Drive continuous improvement initiatives for process efficiency.

Skills

Knowledge of GMP regulations

Problem-solving skills

Organizational skills

Communication skills

Attention to detail

Education

High school diploma or equivalent

Job description

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.

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.