Pre Filled Syringe Engineer -Moulding Disposable Medical Device Ind.

Role & responsibilities

Role & responsibilities- PFS-Engineer.

Job Description

• To ensure smooth running of Pre-Filled Saline Syringes filling, assembly and packaging Line and meet daily and monthly production output targets.
• To train and handle the required manpower (Operators, technician etc.) required for above production line.
• To prepare required SOPs, Work Instructions, Process Parameters and other documents required for effective functioning of above production line
• To co-ordinate with Quality Assurance/Regulatory Affairs dept. for timely validation of production processes.
• To ensure that production takes place as per GMP Guidelines.
• To guide the production operators in case of any problems or issues.
• To trouble shoot any technical problems or equipment problems.
• To ensure the preventive maintenance and up-keep of all equipment.
• Responsible for taking corrective and preventive actions.
• Should have knowledge in 5-S, Kaizen, TPM.
• Should have Break down Analyzing capability. (Root Cause & CAPA)
• To Ensure OEE & Production Improvement .
• Should be Knowledge Saline Water.

Preferred candidate profile

• Must have Experience with filling, assembly and packaging process of Pre filled syringe or working experience in medical industry for any relevant medical products.
• Must have know-how about troubleshooting for PFS filling and assembly machine.
• Good communication skills & well versed with computer operations.
• Capable of handling a team of 10 people including technician, supervisors etc.

Role & responsibilities- PFS-Engineer Moulding

Job Description

• To ensure smooth running Moulding Machine & mould and meet daily and monthly production output targets.
• To train and handle the required manpower (Operators, technician etc.) required for above production line.
• To prepare required SOPs, Work Instructions, Process Parameters and other documents required for effective functioning of above production line
• To co-ordinate with Quality Assurance/Regulatory Affairs dept. for timely validation of production processes.
• To ensure that production takes place as per GMP Guidelines.
• To Ensure Trouble Shooting Moulding Process & Optimize Process parameter.
• To trouble shoot any technical Injection Moulding Machine.
• To ensure the preventive maintenance Injection Moulding Machine.
• Responsible for taking corrective and preventive actions.
• Should have knowledge in 5-S, Kaizen, TPM.
• Should have Break down Analyzing capability. (Root Cause & CAPA)
• To Ensure OEE & Mould Efficiecy

Preferred candidate profile

• Must have Experience with Medical Device Mould & Product Knowledge.
• Must have know-how about troubleshooting for Injection Moulding Machine & Mould.
• Good communication skills & well versed with computer operations.
• Capable of handling a team of 10 people including technician, supervisors etc.
• Should Be Knowledge Plastics Material.