Sr. Team Leader - Equipment Maintenance

Equipment qualification

• Coordination with CFTs in execution of FAT/SAT/DQ/IQ/OQ and PQ of all relevant equipment
• Provide onsite support in start-up and commissioning of new equipment or upgrades to existing equipment
• Prepare specifications for required equipment
• Prepare and ensure availability of working drawings for any activity performed at site
• Prepare Equipment installation drawings and ensure the installation of the equipment as per the same
• Complete periodic inspections of the vendors site to check for the progress of manufacturing of the equipment
• Coordinate with both Internal and External resources for installation of various equipment

Equipment Maintenance

• Study and review standby facilities for critical sub-assemblies and addition of capital equipment on long term basis for smooth operation
• Supports or leads new equipment initiatives by applying existing controls and instrumentation solutions
• Contribute to continuous process improvements initiatives
• Effective communication with original equipment manufacturer to address / resolve the repetitive issues.
• Preventive and corrective maintenance
• Identify, implement and execute preventive maintenance of equipment
• Coordinate with Production to undertake Maintenance requests
• Attend to breakdowns, troubleshoot and rectify basic issues in shortest possible time and to ensure upkeep of the equipment
• Attend to breakdowns, troubleshoot and rectify basic issues of respective electrical systems in shortest possible time and to ensure upkeep of the equipment
• Trend the breakdowns /concerns of the equipment and implement corrective actions to improve the reliability of the equipment.
• Execution of Spare Parts management
• Supporting for the required reliability initiatives at Site
• After Completion of Preventive Maintenance and Corrective Maintenance, ensuring all the data is captured in CMMS.
• Operational and maintenance of Building Management System (BMS) and Environmental Management system (EMS), PMS (Particle Monitoring System) and controls
• Maintenance of Advanced Process Control (APC), Distributed Control Systems (DCS), Programmable Logic Controllers (PLC) and Supervisory Control and Data Acquisition (SCADA) and Variable Frequency Drives (VFD)

Project Management

• Supporting in new/expansion/improvement projects
• To identify continuous improvement initiatives (process improvement, energy efficiency, etc. ) and ensuring to implement them

Reporting

• Prepare monthly reports
• Trending equipment failures / breakdowns and propose corrective actions

Documentation/Compliance

• Change Control Management
• Handling any Deviations/Incidents
• Preparation and Review of respective Documents
• Extending required support during Walkthroughs, Internal Audits & Regulatory Audits
• Initiating purchase requisitions in Procurement System.

Cultural Attributes

• Conduct himself/herself in line with the Values, Courage, Equity, Excellence & Joy

Statutory Obligations

• Conduct himself/herself in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.

Environmental Health and Safety

• Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
• Ensure that all safety instructions and measures are strictly observed.
• Conducting Safety Assessments

Core Competencies

• Detailed knowledge of the following:
• Knowledge of commonly used equipment and machines in pharmaceutical industry
• Experience in implementing standardization procedures and processes
• Conversant with Validation aspects like URS / FAT / SAT /DQ / IQ / OQ / PQ
• Knowledge of preventive and breakdown maintenance
• Should have Knowledge on Installation, Operation and Maintenance of process and packing machines
• Should be conversant with Validation Documents, Preventive Maintenance Schedules / PM check sheets, SOPs & Various Audit Procedures
• Maintenance and troubleshooting of PLCs, DCS, SCADA, VFD and various electronic field instruments and sensors
• Building Management System (BMS) and Environmental Management system (EMS), PMS (Particle Monitoring System) and controls
• Experience in control disciplines such as Advanced Process Control (APC), Distributed Control Systems (DCS), Programmable Logic Controllers (PLC) and Supervisory Control and Data Acquisition (SCADA) and Variable Frequency Drives (VFD)

Standards, Processes & Policies

• Knowledge on Clean room requirements, behavior, good documentation work and Regulatory Guidelines
• Knowledge on metrological standards
• Standard instruments
• Global calibration policies

Qualifications

Must-Have

• Bachelor's Degree
• 8+ years of experience
• Good experience in equipment management and project management
• Direct supervisory experience and understands knowledge management
• Knowledge of Good Manufacturing Practices {also cGMP} OSHA, Food and Drug Administration and environmental regulations applicable to the pharmaceutical Industry
• Strong people management experience
• Strong English speaking and writing skills
• Good computer skills in Microsoft Office suite of products
• Relevant pharmaceutical experience

Nice-to-Have

• Master's degree
• Hands on experience with communication protocols
• Strong technical skills

How You Will Achieve It

• Manage multiple projects and ongoing work activities within a work team.
• Exemplify (Current) Good Manufacturing Practices (part of GxP) compliance within the workplace.
• Prepare department monthly reports, annual expense statements and ensure operational costs are within budget.
• Focus on overseeing defined processes and guiding maintenance colleagues and ensure efficiency and standardization of the maintenance/automation team.
• Organize the Breakdown maintenance, perform the breakdown analysis and implement Corrective Action / Preventative Action.
• Initiate and implement ideas to improve production processes to improve quality, safety and product costs.
• Ensure adequate communication with key stakeholder groups.
• Lead and participate in investigations and continuous improvement initiatives, applying tools, such as LEAN manufacturing and Six Sigma.
• Act as a technical resource during set up, troubleshooting, ensures adequate information transfer to next shift.
• Coordinate with relevant teams to carry out Periodic Performance Verification.
• Ensure a staff training program is in place and verify staff are trained and fully qualified to perform their duties.

Work Location Assignment: On Premise

Engineering

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