What are the responsibilities and job description for the Equipment Specialist - Weekend Shift position at Harba Solutions Inc.?
Aseptic Fill/Finish | Pharmaceutical Manufacturing | Sterile Injectables
Weekend Day Shift -> Friday - Sunday from 6am to 6pm (10% Shift Differential) (2 openings)
Weekend Night Shift -> Friday - Sunday from 6pm to 6am (15% Shift Differential) (2 openings)
Full-Time, Direct Hire with Full Benefits
A pharmaceutical manufacturing organization is seeking an Equipment Specialist to support sterile drug product manufacturing operations. This hands-on role is responsible for operating, troubleshooting, and maintaining production equipment used in aseptic fill/finish processes. This individual will play a key role in supporting manufacturing operations by ensuring equipment is properly prepared, operating efficiently, and meeting GMP quality standards. The position will also assist with equipment improvements, troubleshooting, and technical support for the production team.
Key Responsibilities
- Set up, operate, and perform changeovers on pharmaceutical production equipment (changeovers are a requirement)
- Support batch start-up activities and execution of manufacturing cycles
- Perform work within controlled manufacturing environments including cleanrooms (Grade A and Grade C)
- Execute aseptic operations within isolator systems when required
- Document manufacturing activities and complete batch records in accordance with cGMP requirements
- Assist with equipment troubleshooting, repairs, and preventative maintenance
- Support validation runs, engineering batches, and equipment qualification activities
- Serve as a technical resource for filling equipment and related manufacturing systems
- Train manufacturing staff on equipment operation and production procedures
- Participate in process improvements and equipment optimization initiatives
- Work with engineering, operations, and quality teams to resolve production issues and maintain operational efficiency
Basic Qualifications
- High school diploma or equivalent required
- Approximately 7 years of experience working with GMP pharmaceutical manufacturing equipment
- Hands-on experience installing, operating, cleaning, and maintaining production equipment in a regulated environment
- Strong mechanical aptitude and troubleshooting abilities
- Proficiency with basic computer systems (Microsoft Office or similar tools)
Preferred Background
- Bachelor’s Degree in a Science related discipline
- Experience supporting aseptic or sterile injectable fill/finish manufacturing processes
- Working knowledge of cGMP standards and pharmaceutical manufacturing operations
- Familiarity with SAP/ERP, inventory, or manufacturing systems
- Strong communication skills and ability to support cross-functional teams
Work Environment
- Pharmaceutical manufacturing facility supporting sterile drug product production
- Cleanroom and controlled production areas (Grade A and Grade C)
- Weekend manufacturing schedule supporting critical production operations