Production Specialist

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

Job summary

A manufacturing company in the pharmaceuticals sector is seeking candidates for a role focused on executing manufacturing activities while ensuring compliance with safety and quality standards. Applicants should have an Associate’s or Bachelor’s degree in a relevant field or equivalent experience and at least one year of work under cGMP standards. Candidates will operate specialized equipment and maintain documentation while working collaboratively within a team environment.

Qualifications

• 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.

Responsibilities

• Execute manufacturing activities following approved batch records and SOPs.
• Set up, operate, and maintain specialized production equipment.
• Complete documentation accurately, including batch records and logs.

Skills

Attention to detail

Ability to follow procedures

Comfortable with repetitive tasks

Education

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

Equivalent experience in a regulated manufacturing or aseptic environment

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