Engineering Manager

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Responsibilities:

• The Manager, Engineering leads projects to develop engineering solutions for operational issues or new processes. 
• This position implements system improvements of capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team, develops processes that lead to shortened cycle time and makes impact decisions while supporting the policies, goals and objectives of the company.
• Participate in objective setting, plan development and performance review of plant performance
• Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance
• Defines roles and accountabilities to avoid duplicate functions
• Reviews and approves IQ/OQ/PQ test documents, SOPs and Preventative Maintenance work plans for new/upgrade equipment and systems
• Manages external engineering services and recommends resources required to carry out projects or improvements
• Routinely has direct contact with outside consultants, technical counterparts from key vendors Budget monitoring, control, and trend tracking
• Responsible for maintaining qualified state of all active equipment and systems
• Administers key systems including CCMS/CMMS, EMS
• Prepares and maintains departmental policies, SOPs and document templates
• Controls revisions of critical facility and utility drawings
• Acts as subject matter expert during inspection and audits
• Supports safety, health, and environmental policies and procedures
• Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times
• Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff
• Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments
• Communicates directly with the operations departments to coordinate engineering activities
• Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures
• Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects
• Assists with planning and implementing plant improvements and expansions
• Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems
• Initiates and carries out projects that improve efficiency and/or reduce operating costs
• Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement
• Assists with deviation investigation and identifies areas for CAPAs as needed based on root causes.
• Sources and procures equipment, supplies and other materials as needed.

Requirements:

• Bachelor of Science in Engineering or Science discipline preferred
• 3 years of experience in pharmaceutical engineering, pharmaceutical operations, and operations management
• In-depth knowledge of the pharmaceutical plant operations is an asset
• AutoCAD
• CCMS/CMMS software (Blue Mountain Regulatory Asset Manager)
• EMS/BMS
• PLC programming and electrical troubleshooting