Production - Packing Line & Device Assembling Shift In charge

Biological E; New Delhi; Sur place; INR 600 000 - 1 000 000; Plein temps

Résumé du poste

Biological E in Delhi is seeking a hands-on Operations Engineer to manage shift operations for device packing lines, oversee automated packaging machinery, and minimize downtime through proactive troubleshooting.

The role requires experience in GMP documentation, IQ/OQ/PQ qualification processes, and collaboration with cross-functional teams including OEMs.

Qualifications

• Hands-on experience in a pharmaceutical or medical device packing facility.
• Experience with device packing machines and packaging lines; familiarity with Pen devices and Auto-injectors is a plus.
• Knowledge of GMP/QA documentation practices and regulatory expectations (USFDA, MHRA).
• Ability to coordinate with cross-functional teams and ensure quality during packaging operations.

Responsabilités

• Manage shift operations for device packaging lines to hit production targets safely and efficiently.
• Operate and oversee automated device assembly and packing machinery.
• Troubleshoot mechanical and electronic issues on Pen device and Auto-injector packaging equipment to minimize downtime.
• Monitor performance, optimize cycle times, and ensure product quality during assembly.

Connaissances

Device packing

Shift management

Regulatory knowledge

Troubleshooting

Description du poste

Hands-on experience in a pharmaceutical or Medical device Packing facility.

Shift Operations & Equipment Management

• Manage shift operations for the device packaging lines to meet production targets safely and efficiently.
• Operate and oversee automated device assembly and packing machinery.
• Troubleshoot automatic machine mechanical and electronic issues on Pen device and Auto-injector packaging equipment to minimize downtime.
• Monitor machine performance, optimize cycle times, and ensure product quality during the assembly process.

Qualification & Validation

• Lead the qualification processes (IQ / OQ / PQ) for all device assembly, packaging equipment.
• Collaborate with cross-functional teams to execute validation protocols for new and modified equipment.

Documentation & Compliance

• Prepare, review, and maintain standard GMP documentation, Standard Operating Procedures (SOPs), and batch records.
• Conduct risk assessments and execute mitigation strategies for packaging processes.

Required Technical Skills

• Direct, proven experience in handling Device Packing machines, specifically with Pen devices and Auto-injector packaging technologies.
• In-depth knowledge of regulatory requirements (e.g., USFDA, MHRA)

Preferred Behavioural Attributes

• Shift Team handling
• Excellent communication skills for project documentation along with CFT & OEM.