The Manufacturing Technician will support manufacturing operations during facility startup, commissioning, qualification, and routine production activities. The role is responsible for performing manufacturing activities according to approved procedures, operating production equipment, completing GMP documentation, and supporting process validation and operational readiness activities.
Working closely with Manufacturing, Engineering, Quality Assurance, and Technical Services teams, the Manufacturing Technician will ensure production activities are performed safely, efficiently, and in compliance with cGMP requirements.
Responsibilities
Startup, Commissioning & Qualification Support
- Support manufacturing activities during facility startup, equipment commissioning, and qualification activities.
- Assist with equipment setup, operational checks, trial runs, engineering runs, and qualification batches.
- Support IQ/OQ/PQ activities by performing assigned manufacturing tasks, equipment operation checks, and data recording.
- Provide feedback on equipment operation, process flow, and work instructions to support manufacturing readiness.
- Report equipment issues, process concerns, and operational challenges to supervisors or engineers.
Manufacturing Operations
- Perform manufacturing activities according to approved SOPs, batch records, work instructions, and GMP requirements.
- Operate manufacturing equipment and production systems safely and effectively.
- Perform equipment setup, line clearance, material loading, equipment cleaning, and changeover activities.
- Monitor process parameters and equipment conditions during manufacturing operations.
- Perform in-process checks and ensure accurate recording of manufacturing data.
- Escalate any abnormalities, deviations, or safety concerns promptly.
GMP Documentation & Compliance
- Complete batch records, logbooks, checklists, and electronic documentation accurately and in a timely manner.
- Follow Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and site procedures.
- Maintain proper documentation traceability and ensure records are completed according to requirements.
- Support investigations by providing accurate information related to process events, equipment issues, and manufacturing activities.
Process Validation & Continuous Improvement Support
- Support process validation activities, including validation batches and process verification runs.
- Assist with troubleshooting activities and provide observations from manufacturing operations.
- Participate in continuous improvement activities to improve safety, quality, productivity, and operational efficiency.
- Support 5S, Lean Manufacturing, and workplace improvement initiatives.
Safety & Quality Responsibilities
- Perform all activities in accordance with Environmental, Health & Safety (EHS) requirements.
- Follow safety procedures, including proper use of personal protective equipment (PPE) and safe equipment operation practices.
- Maintain a clean and organized manufacturing environment.
- Ensure product quality is protected by following approved procedures and reporting any potential quality risks.
Training & Team Collaboration
- Complete required training and maintain qualification status for assigned manufacturing tasks.
- Support onboarding and knowledge sharing with new team members when required.
- Work collaboratively with Manufacturing, Quality, Engineering, and other support functions.
- Participate in shift handovers and team meetings to ensure effective communication.
Qualifications
- Diploma or technical qualification in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Manufacturing, Mechanical Engineering, or related disciplines.
- Minimum 1–3 years of experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments preferred.
- Experience with GMP manufacturing operations, cleanroom activities, equipment operation, or production processes is an advantage.
- Basic understanding of cGMP, GDP, safety requirements, and regulated manufacturing practices.
- Experience with batch documentation, SOP execution, and manufacturing systems preferred.
- Good attention to detail and ability to follow written procedures accurately.
- Ability to work in a cleanroom environment and support shift operations when required.
- Good communication skills and ability to work effectively as part of a cross-functional team.
