Production Technician I

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.

Responsibilities:

• Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.
• Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.
• Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.
• Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.
• Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.
• Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.
• Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.
• 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.
• Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.
• Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.
• Comply with all Environmental Health & Safety (EHS) standards and maintain a clean and safe work environment.

Key Stakeholders

Internal

• Production Supervisor and Production Manager
• Engineering and Maintenance
• Validation and Quality Assurance
• Materials and Warehouse Teams
• Environmental Health & Safety (EHS)

External

• Equipment vendors and service technicians (as required)

Requirements:

Qualifications & Experience

• High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.
• Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.
• Prior experience with sterile products or IV bag manufacturing strongly preferred.
• Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.
• Experience operating automated production equipment using HMI or SCADA interfaces required.
• Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.
• Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.

Skills & Competencies

• Strong technical and mechanical problem-solving skills
• High attention to detail with a commitment to quality and data integrity
• Ability to work effectively in a fast-paced, highly regulated environment
• Strong verbal and written communication skills
• Team-oriented mindset with a collaborative approach
• Comfortable working in cleanroom environments with PPE requirements