What are the responsibilities and job description for the Director of Engineering position at Piramal Pharma Solutions?
The Director of Engineering directs and coordinates the activities of the plant Engineering staff to design plant facilities, manage construction activities, maintain environmental compliance, identify and take action in areas of energy conservation, maintain best practices to ensure cGMP compliance, and comply with various regulatory requirements pertaining to engineering activity. The position provides technical leadership and administrative control to ensure efficient operations and management of plant equipment and engineering functions, maximizes capacity and optimizes utilization of resources, and develops systems and processes for high performance delivery
Role
•To ensure efficient operation, maintenance and upkeep of Plant Equipment and Utilities.
•To maintain, improve and keep updated all Engineering Documents and records
•Ensure compliance to Quality, Safety and Regulatory requirements.
•Ensure compliance of SOPs, cGMP practices along with good documentation and record keeping, periodically reviewing departmental SOP's.
•Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
•Ensure execution of Preventive & breakdown maintenance activity as per SOP.
•Maximizing plant uptime by keeping track of OEE & breakdown reports.
•Meet internal customer expectations on costs and quality deliverables
•Control engineering costs and ensure they remain within reasonable variance of sanctioned budget.
•Ensure uninterrupted utility services to plant to achieve targeted production.
•Identify area of energy conservation, plan propose and drive Energy Conservation projects and initiatives.
•Monitor & control the Engineering CAPEX and OPEX budget.
•To ensure that Engineering team delivers as per the KPIs.
•Ideation and implementation of cost optimization/de-bottlenecking projects
•Participate in various operational projects like ERP, refurbishment / modification of areas
•Provides direction and guidance to ensure quality, safety, and regulatory compliance with applicable federal, state, and local environmental regulations, company policies and procedures, and GMP
•Responsible to maintain knowledge of changes or updates to requirements and share those changes with Engineering and Facilities department
•To perform functions of the MR (Management Representative) of EHS management system.
1.Responsible for effective implementation of EHS Management system in accordance with the requirements of ISO 14001:2015 and ISO 45001:2018.
•Directs the training and development of facilities and engineering employees to ensure task completion. participates in team development activities and ensures staff operates successfully in a team environment
1.Identify training needs where necessary to ensure department success
•Coach employees and manage department challenges with the help of HR.
•Conduct Departmental Meetings – A two way communication process for reviewing various points for improvement in the dept.
Requirements
•Bachelors degree in Mechanical Engineering or related technical/engineering field with 10 years of related experience or Masters degree in Engineering or related field with 5 years of related experience
•Experience independently handling engineering and maintenance functions of manufacturing unit involved in drug products (sterile and non-sterile dosage forms)
•Experience with regulatory and customer audits
•Individuals with equivalent combination of education, training, and related experience will be considered
•Knowledge of or working in the following areas; Project Management, Special Projects, Validation, production processes such as Granulation, Encapsulation, Packaging
