Team Leader - Engineering Lactam

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 maximizes 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 optimize 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

Develop and implement preventive maintenance schedules for the following Equipment.
Production Equipment:

Tablet Compression, Tablet Sorting, Granulator, Capsule Filling, Tumbler, Tablet Film Coating, Homogenizer, Metal detector with de-duster, Bin Washing Station & Russel Siever.

Packaging Equipment:

Blower, Powder Filling, Capping, Labelling, Induction Aluminium Foil Sealing, Cartoner, Blistering, 2D Barcode Printing/Inspection, Steam Sterilizing Autoclave, Filling + Closing for Vials, Ultrasonic Cleaning for Vial, Hot Air Tunnel, Labelling, Aggregation systems and serialization systems.

Leads the Maintenance and Reliability team focused on Preventive & Predictive Maintenance to maximize 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 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:

The Team Leader is a dynamic leader with strong aptitude, master of technical knowledge and very strong understanding and adherence to Compliance.
You are highly results oriented with strong sense of accountability & ownership.
You have excellent planning skills and able to consider multiple aspects including People, GMP, Safety and technical complexity to deliver desired outcomes.
Strong communication and interpersonal skills, ability to collaborate across teams and influence others.
Able to find solutions to problems and make decisions to execute solutions in short time frame.
High on adaptability and able to cope with change.
Team oriented with ability to motivate and develop team members.

Qualifications:

Bachelor's degree in Engineering Subject.
7+ years' experience in pharmaceutical industries.
Strong knowledge in pharmaceutical equipment design and functionality principles.
Strong knowledge for equipment installation & qualification (IQ, OQ, PQ).
Experience in managing and delivery Small to Medium sized projects.
Highly skilled and experienced in Preventive & Corrective Maintenance of equipment.
Deep understanding of cGMP regulations and requirements for pharmaceutical manufacturing including facilities and utilities.
Experience in SAP System & EQMS.
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