Position – Head of Process Engineering & Maintenance
Duties And Responsibilities
- Lead the site engineering/maintenance of all process and QC lab equipment
- Develop and maintain technical collaboration with multiple critical process equipment vendors (Domestic and Global)
- Ensure compliance to Regulatory/GMP requirements from engineering & maintenance perspective
- Provide leadership to the team of engineers to ensure timely technical resolutions in line with agreed procedures
- Propose and implement optimisation project to improve performance, quality, and compliance.
- Ensure timely decisions and assist resolving complex problems by effective coordination among site engineering/maintenance, Quality and operations as per site needs.
- Ensure timely approvals of all necessary regulatory & GMP documents.
- Develop preventative maintenance SOPs & PM Plans of all process equipment & ensure adherence to PM schedules & SOP training in timely manner,
- Networking with other site engineering & maintenance functions
- Support improvement of OEE
- Manage shift support to operations
- Manage essential spares of all process equipment & coordinate with procurement and engg. WH
- Manage maintenance contracts with OEMs as appropriate
- Prepare budget & ensure adherence
- Bachelor or master degree in Electronics and Instrumentation Technology/Mechanical/Electrical
- Min 20 years of relevant work experience in pharmaceutical Formulation filling and engineering maintenance.
- Detailed knowledge of pharmaceutical quality, manufacturing operations, operations and maintenance of Integrated filling line, formulation skids & associated equipment.