Job Description

Purpose:
To lead & manage the Integrated Engineering and Infrastructure Projects function With the objective of Ensuring maximum availability of equipment and facilities, both Plants and Labs for the intended purpose to meet a business needs, complying with quality / SHE requirements. Planning and Executing capital projects and continuous improvement projects for productivity, reliability, and compliance along with min downtime and loss of production. Meeting business goals through capacity expansion, upgrade of existing facilities, and implementing energy conservation initiatives towards long-term sustainability & reliability.

Roles and Responsibilities

Preventive & breakdown maintenance Maintaining plant and lab equipment to ensure correct functionality and calibration compliance. Operation of manufacturing equipment and automated systems within the validated process parameters. Developing and guiding the team towards zero downtime concept, higher reliability, maximum availability, and zero failure contributing to batch loss due to equipment. Ensuring good breakdown analysis and driving towards a strategy for comprehensive handling of critical breakdowns. developing and improving preventive maintenance IN ORDER TO ensure that production of batches runs seamlessly in plants and Experiments are conducted smoothly in labs.

Continuous improvements and cost management (CAPEX/OPEX) Ensure effective and efficient production operations across all plants and experiments across labs, leading team to identify continuous improvement opportunities, debottlenecking, life cycle management of critical equipment, LDM & TPM initiatives, energy & resource optimization for higher productivity, networking with other DRL units, cost efficiency, KPI development, and monitoring. Preparing and supporting in developing CAPEX proposals, feasibility study, and approvals. ensuring timely execution of projects with timeline and compliance in order to ensure accurate budgeting for OPEX, tracking, and monitoring to keep the cost within targets.

Infrastructure Project Management - Planning & Execution Develop infrastructure project plan; Oversee that SLA is followed for purchase activities (approvals, technical negotiations, material delivery); Review project progress within defined scope, budget and timeline; Troubleshoot roadblocks in implementation and escalate to the relevant stakeholders as required. Prepare, review periodically and update the Site Master Plan to ensure optimum utilization of facilities; Propose recommendations to upgrade as required; Present infrastructure plan which includes concept plan (front end engineering design), budget, timelines to the BU leadership (BMC) for approval; Identify and appoint consultants for the development of detailed plans; Share the business asks and expectations with the consultants required for detailed engineering plan; Present proposals and periodic updates to stakeholders; For brownfield projects, develop implementation plans with minimal impact on business continuity and everyday operations and get buy-in
IN ORDER TO meet the business requirements by completing projects as per agreed time, scope, and budget

Commissioning, Qualification, and validation including capacity creation in Mfg / Labs Work with function heads in manufacturing, development, engineering to finalize decision for capacity creation in Mfg / Development Labs. Issue discrepancies and work with cross-functional departments to close the discrepancies and implement appropriate corrective actions; Comply with all relevant GMP, safety standards, and SOPs of the operation of designated manufacturing and lab equipment. Complete batch documentation in compliance with GMP. Collection and maintenance of data in accordance with cGMPs, company standards, policies, and other regulatory requirements; Maintaining manufacturing and lab equipment to ensure correct functionality and calibration compliance. Operation of manufacturing equipment, analytical equipment, and automated systems within the validated process parameters in order to enable capacity creation towards commercial supplies/lab capability and ensure that the batch and experiments run on qualified and reliable equipment.

Safety, quality, and statutory compliances QMS elements are managed effectively by the team. Training needs are identified and conducted to promote GMP practices, avoid noncompliance with respect to Quality. Ensure all facilities are maintained for audit readiness. Audit compliances are addressed in time. All documents & procedures are developed, revised, and maintained as required. in order to ensure compliance to cGMP and Regulatory requirements, ensure safe and hazard-free production and lab operations. Lead team by example & actively promote safety awareness and improvements. Proactively engage in continuous improvement activities for safe and compliant equipment operations; Adhere to the company's safety rules and standards /guidelines. Ensure team conducts all work in a safe manner, encourage and ensure all unsafe matters and near-miss /accidents are reported, investigated, and close in time. Ensure environmental KPI and requirements are met as per EMS plan.

Centre of Excellence (CoE) - Simplification, Harmonization, Digitisation, Automation, Mechanization, GEP Identify opportunities in engineering to simplify the processes & eliminate the waste; Ensure harmonization of SOP's / Procedures & elimination of non-value-added processes & practices. Review major equipment and automation performance metrics for reliability.
Review good engineering practices, guidelines for Dr.Reddys e.g. Water systems, automation practices, HVAC, etc.; Ensure all the procedures are adhered to & deviations are escalated to quality management systems. Identify opportunities and prepare a roadmap for automation & mechanization to support business needs & minimize manual interventions in order to Harmonize engineering practices across sites, reduction in waste / non-value-added practices, quality observations, reduce open handling operations, and use of muscle power.

People Management In order to have a capable, high-performing, and motivated team to support plant operations, lab operations, and infrastructure projects. Goal setting/performance reviews: skill development, training and coaching employees; effectively managing employee performance issues and corrective actions; engaging, recognizing, and appreciating employee contributions, and all other activities/functions which support the achievement of individual/department/business objectives in order to build a highly motivated and productive team. Ensuring organization effectiveness, optimized resource management, and capability building

Desired Candidate Profile

Engineering Graduate with +20 yrs of experience in a senior or similar position handling maintenance and project activities and leading a team of mechanical, electrical, civil, instrumentation and automation engineers in pharma / API/ Biotech industries

10 years in a Leadership role in engineering & project function and cross-functional exposure in pharma/ Biotech.

Understanding of pharma process, quality, safety, purchasing, and cost management.