Tasks / Responsibilities
Should have very good knowledge of Pharma machinery, and equipment along with standard utility equipment like Boilers, air compressors, Brine and water chilling plants, Nitrogen plant, hot oil heating units HVAC system, water treatment plants: both working principles and maintenance work
Should have good knowledge of energy conservation program implementation & track record of energy saving
Knowledge of condition monitoring, NDT and predictive maintenance
Utility performance reporting and presentations
Should have good working knowledge of principles of GMP, quality systems and documentation and how to apply it to engineering department
Demonstrate Comprehensive leadership and management of Good Engineering Practices (GEP)
Internal audit & inspection w.r.t. Safety, Instrumentation, Thermography, GMP Audit of Engg. Functions only & Computer Validation)
Tracking of IBR, Statuary & Regulatory Compliance as per timeline
Well versed with regulatory compliance with key roll in Validations, HVAC, Water and critical systems as per ICH and WHO guidelines
Having Comprehensive approach in delivering key results with Plant Energy conservation and cost effectiveness.
Preparation & Execution of Validation Protocols for Plant, equipments & facilities
Formulation of Standard operating procedures & implementation
Creation of job instructions & method statements for engineering activities
Change control system & Plant modification system
Engineering drawing control mechanism
Log books & event management
Organizing Investigation of Major Breakdown through why-why analysis or any other tool
Responsible for New technology assessment, equipment retirement and disposal & transfer of Assets
Maintain the validation & regulatory status To ensure all plant & machinery is maintained as per regulatory status & validation status (US FDA, TGA, MHRA, WHO). Ensuring customer requirements & facing various audits.
Delivery performance Ensuring day to day delivery performance
Deviations To ensure no deviations, development of CAPA for engineering issues
OPEX & CAPEX Developing budgets for maintenance & improvements. Ensuring all budgets are met, delivery of all capital initiatives.
Performance Improvements Ensuring continuous improvements & engineering excellence for sterile complex.
Systems Implementation Development of systems for Engineering function & implementation for ensuring system based operations.
Trainings Development of training modules & imparting trainings on GEP, cGMP, OJT & SAP trainings.
Designing Developing engineering requirements for new plants. Development of basic engineering packages, engineering specifications, containment strategies, GMP, GEP requirements
EHS Policy Ensuring implementation of EHS policy, ensuring day to day compliance to EHS
Corporate framework Development of corporate framework for EHS. Development of guidelines & standards.
EHS Risk assessments To carry out risk assessments for all activities, identification of risks, prioritization & ensuring mitigation of risks.
Industrial Hygiene Implementation of Industrial hygiene studies, mass balance analysis. Ensuring containment strategies for OEB categories. Ensuring ongoing compliance on exposure controls.
Optimum performance of Plant & Machinery: To ensure that Plant & machinery delivers consistent performance through out the production cycles. Plan the Engineering strategies to improve plant performance & deliver right product at right time & at right cost. Ensure optimum utilization of manpower & CREATE high performance behaviors within Engineers & staff. Support innovations & technology to for continuous improvements. Ensure EHS procedures & practices are followed to have Zero loss time accidents & zero non compliances.