Inspection Technician

Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.

By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.

Role Description:

• Purpose Statement The Inspection Technician is responsible for sterile pharmaceutical inspection operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.
• This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures.
• The Inspection Technician serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.
• This position will include cross training for support of formulation, IV Bag filling, leak inspection, dispensing and packaging.

Responsibilities:

• Operate, monitor, and adjust IV Bag inspection equipment and direct 100% inspection of filled IV-bags of various sizes and configuration.
• Secondary responsibilities will include operating manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.
• Perform visual inspection of final product to ensure conformance with quality standards and specifications.
• Perform AQL testing manually to verify integrity of the automated inspection system.
• Serve as first-line troubleshooting support for equipment and GMP manufacturing issues, escalating to engineering or maintenance as required.
• Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.
• Assist in the creation, revision, and implementation of SOPs and production-related procedures.
• Provide training, guidance, and on-the-job support to other production personnel.
• Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.
• Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.
• Review documentation completed by fellow members of the production team.
• Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.
• Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.
• Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.
• Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.

Requirements:

Qualifications/Experience

• High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.
• Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of product post fill inspection.
• Experience with sterile products or IV bag production preferred.
• Demonstrated mechanical aptitude with skills including the ability to concisely describe problems to mechanics.
• Knowledge of cGMP, and aseptic processing, requirements.
• Minimum of 3 years’ experience working with automated production equipment utilizing HMI required. Experience with a supervisory controller and data acquisition system (SCADA) interface will be a plus.
• Experience with isolator-based manufacturing strongly preferred.
• Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols

Skills/Competencies

• Precise skills for inspecting finished product effectively.
• Demonstrated problem-solving and troubleshooting skills.
• Ability to mentor and train less experienced technicians.
• Excellent attention to detail and documentation accuracy.
• Effective communication and teamwork skills.
• Commitment to safety, quality, and data integrity.
• Comfortable working in cleanroom environments with PPE requirements.