Job Description

• Hands on experience on injectable process equipment like Vial filling lines, PFS filling lines, Isolators, Lyophilizers, and Steam Sterilizers maintenance and ability to lead team of 5-10 members.
• Implementation and review of departmental documentation, validation & QMS activities. Shall have Hands-on experience on Change Control Management, Investigations & CAPA modules. Tracking allocated QMS task completion and closer within time.
• Analysis of breakdown notifications.
• Planning and execution of SAP preventive maintenance and timely closure.
• Maintaining and procurement of critical spare parts. Should be innovative, self-starter and work within the allocated budget. Focus on reverse engineering.
• Develop and coordinate with external vendors for and developing of indigenous spare parts and maintenance activities.
• Lead continuous improvement initiatives in the filling lines to increase process efficiency, energy conservation and capacity while maintaining a high level of quality.
• Ensure compliance to cGMP and quality system.
• Having exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc.
• Prepare the budget and capex for the engineering department and monitoring of yearly expenditure of engineering department.
• Ensuring compliance of safety policies, safe work environment for all the team members, external party, contractors etc.
• Legal compliance with respect to safety & environment, licensing with government authorities.

Work Experience
8 to 10 years
Education
Diploma
B.Tech in Electrical or Mechanical Engineering
Competencies
1. Strategic Agility
5. Result Orientation