Production Specialist

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 45,000 - 60,000; Full time

Job summary

A leading biotechnology firm in Indianapolis is seeking an Associate to execute manufacturing activities in a cGMP environment. Responsibilities include operating specialized production equipment, ensuring material traceability, and adhering to strict safety and quality standards. Ideal candidates will have a science-related degree or relevant experience and the ability to work in controlled environments. This full-time position offers an opportunity to be part of a collaborative manufacturing team.

Qualifications

• 1 year of experience working under cGMP or similar standards.
• Ability to lift up to 35 pounds.
• Comfortable working under controlled conditions.

Responsibilities

• Execute manufacturing activities following approved guidelines.
• Set up and maintain production equipment.
• Complete documentation accurately.
• Support compliance and environmental monitoring.

Skills

Attention to detail

Ability to work in cleanroom environments

Ability to follow procedures

Comfort with repetitive tasks

Education

Associate’s or Bachelor’s degree in a scientific, technical, or engineering field

Equivalent experience in regulated manufacturing

Job description

Responsibilities

• Execute manufacturing activities following approved batch records, SOPs, and safety guidelines
• Set up, operate, and maintain specialized production equipment in controlled environments
• Prepare and verify materials while maintaining strict material traceability
• Perform routine cleaning, sterilization, and production readiness activities
• Complete documentation accurately, including batch records and production logs
• Support environmental monitoring and compliance activities as required
• Adhere to all cGMP, safety, and quality standards
• Participate in training, qualification, and validation activities
• Assist with investigations, deviations, and inspections when needed
• Work collaboratively within a shift-based team environment

Required Qualifications

• Associate’s or Bachelor’s degree in a scientific, technical, or engineering field preferred
• OR equivalent experience in a regulated manufacturing or aseptic environment
• At least 1 year of experience working under cGMP or similar regulatory standards
• Ability to work in cleanroom or controlled environments for extended periods
• Strong attention to detail and documentation accuracy
• Ability to follow written procedures and verbal instructions
• Comfortable performing repetitive, precision-based tasks
• Ability to lift up to 35 pounds

Seniority level

• Associate

Employment type

• Full-time

Job function

• Manufacturing

Industries

• Pharmaceutical Manufacturing and Biotechnology Research