Job Description:
- The Value Stream (VS) Engineering Team leader will lead the Engineering team supporting operations and manufacturing in the Value Stream (VS).
- The Team Leader will be a member of the VS leadership team, working closely with the VS leader and other functional leads to manage the daily operations and production plan.
- Responsible for equipment (Production/ Packaging) maintenance and repair operations across all three shifts.
- Manages and guides the Engineering staff to plan and safely execute their activities in coordination with the cross functional team and the plan.
- Drives a mindset focused on Preventive & Predictive maintenance that maximises equipment up-time and OEE. Deliver 100% of planned maintenance on time.
- Accountable for delivery of maintenance tasks following the appropriate safety standards and in compliance with our SOPs and policies.
- Motivate and develop the skills and competencies of team to better support the Technologies, Systems and Equipment operating in the Value Stream.
- Make use of Data and KPIs to understand and report equipment performance and to target continuous improvement activities.
- Collaborate with other VS Engineering Team Leaders teams and equipment suppliers to optimise maintenance strategies (both Mechanical & Electronics) for equipment and processes.
- Play a key role in the preparation of URS, Technical Specifications and facility requirements for new equipment and projects.
- Collaborate with HOD to prepare the annual OPEX budget and track spend on Monthly basis to stay within budget. Drive cost savings through improvement activities.
- Responsible for the creation and upkeep of a Facility Master Plan (FMP) for the VS.
- Responsible for the Backup, Restoration and Disaster Recovery of equipment as per procedures.
- Responsible for equipment obsolescence management within VS. Identify gaps in control systems and seek funding through FMP process to manage life cycle of equipment.
- Manage the spare parts holding for the VS equipment. Follow spare parts holding procedures to balance parts availability with Inventory levels.
- Lead new equipment installation, commissioning, Testing & Validation.
- Maintaining all the Manuals, Drawings and Specifications for VS equipment.
- Responsible for preparing for internal and external audits to be ready with required records, data, preventive maintenance documents and SOPs
- Hold team to account for QMS activities such as: CAPA, Deviation, Change Control and Standard Operating Procedures.
- Responsible for and competent in the operations of the Aggregation and serialization systems in VS in coordination with the System SME.
Specific Job Description:
- Drives the Maintenance and Reliability initiative focused on Preventive & Predictive Maintenance for the following Sterile Production & Packaging Equipment.
- Freeze Dryer, Ampoules + Vials Washing, Dry Hot Air Sterilizing Tunnel, Ampoule Filling + Sealing, Vial Filling + Closing, Continuous motion vial closing, Labelling, Bottle + Ampoule Rinsing, Ultrasonic Cleaning, Fully Automatic Inspection, Semi-Automatic Inspection, Sterilizer (Autoclave), Steam Sterilizing Autoclave, Fully Automatic closing for Vial & Cartoner, Aggregation, Track & Trace system.
- Leads the Maintenance and Reliability team focused on Preventive & Predictive Maintenance to maximise equipment and facility up-time and OEE.
- Diagnose and troubleshoot equipment failures and perform root cause analysis.
- Collaborate with share resources with other VS Engineering teams to ensure timely and effective repairs.
- Analyse equipment performance data to identify opportunities for improvement.
- Implement process improvements to enhance equipment efficiency and reduce downtime & maximizing the equipment uptime. Timely closure of breakdown notifications to achieve desired KPI results for overall team performance
- Upgrade and overhauling existing equipment to enhance performance and reliability.
- Responsible to identify the gaps in obsolete control systems and carrying out the upgradation activities of the machinery according to the proposed solution based on criticality (auditing 21 CFR & business risk).
- Maintain accurate and up-to-date equipment documentation, including maintenance records.
- Responsible for OPEX (Spare Parts/ Service) requisition & follow-up
- Responsible for SCADA
- Responsible for preparation of weekly and monthly breakdown and overview report, analysing the data trends.
- Review and closure of SOP revisions, Deviations, CAPA, and CCR without overdue, through the tracking system and Quality Management System.
Core Competency:
1. The Team Leader is a Dynamic Leader with strong aptitude, master of technical knowledge and very strong adherence to Compliance having critical thinking ability
2. In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
3. You have excellent Business Acumen and Strategic Planning skills for diversified Project Management experience coupled with strong influencing skills with emotional intelligence
4. Strong communication, interpersonal skills, Service Orientation and project management skills required.
5. Must have a solution centric mind to understand issues and solve them within a stipulated time frame, should possess decision making skill for smooth functioning
6. High on adaptability and change management skills
7. Excellent team building, strong time and task management for self and team
Qualifications:
1. Bachelor’s degree in engineering Subject
2. 10+ years’ experience in pharmaceutical industries
3. Knowledgeable with all types of Electronics & Mechanical, its parts and operation
4. Expertise knowledge for equipment installation & qualification.
5. Expertise in Project Management
6. Expertise in Preventive & Corrective Maintenance of equipment.
7. Expertise in cGMP regulations and requirements for manufacturing-facility utilities that includes understanding of cGMP compliance within controlled.
8. Prepare risk assessments for mechanical & electronics systems
9. Experience in SAP System & EQMS
