Senior Manager, Engineering - Pharmaceuticals

The Senior Manager, Engineering will be heading Mechanical and Electrical engineering operations for the plant.

This position is responsible for providing enduring technical excellence across a number of operational functions for the company. The incumbent will have a leadership role with technical contributions for regional initiatives. This position requires strong personal initiative to identify opportunities, achieve engineering standardization and implementing Best Practice across the manufacturing facilities.

This position works closely with the factories in the region as well as regional Operation, Supply chain, Business development, QA, R&D and other cross functional groups to ensure technical alignment.

Externally, this position requires working with local and global engineering solution providers to source the best and the most innovative solutions for all technical initiatives as well as leverage engineering resources to support the region’s needs.

Responsible for:

• coordinating all activities related to the planning, execution, commissioning, and turnover of engineering at the Monroe, North Carolina facility.
• adhering to good engineering practices at the site.
• coordinating tasks in accordance with cGMPs and site Quality and Engineering procedures.

• Responsible for safety and the adherence to policies and regulations to ensure that all engineering tasks are performed in a safe manner.
• Leads regional engineering standardization for Global Engineering as related to projects and processes in order to provide common tools for estimating, project documentation, and equipment evaluation to improve speed to market on new products.
• Provides feasible process & controls, as well as associated capital estimates and timelines for new marketing initiatives by coordinating with Global Engineering, Technical Platform Experts, machine suppliers and internal customers.
• Provides engineering support activities for manufacturing facilities, which include major capital projects, equipment upgrades, facility expansion and/or upgrades, major equipment and system purchases as well as installations.
• Demonstrate Comprehensive leadership and management of Good Engineering Practices (GEP)
• Lead and build Empowered Engineering & Maintenance (E&M) Teams and provide them continuous support in achieving quality output.
• Oversee the E&M operations and review.
• Experience to deal with foreign consultants & inspectors
• Harmonization of E&M policies and GEP across the organization
• Preparation of Corporate Guidelines and Corporate E&M Manual
• Weekly/Month/Annually Engineering function reviews.
• Ideal Assets and budget Utilization
• Internal audit & inspection w.r.t. Safety, Instrumentation, Thermography, GMP Audit of Engg. Functions only & Computer Validation)
• Tracking of Statutory & Regulatory Compliance as per timeline.
• Well versed with regulatory compliance with key roll in Validations, HVAC, Water and critical systems as per relevant guidelines.
• Having Comprehensive approach in delivering key results with Plant Energy conservation and cost effectiveness.
• 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,). 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, OHSAS & SAP trainings.

• Designing– Developing engineering requirements for new plants. Development of basic engineering packages, engineering specifications, containment strategies, GMP, GEP requirements

• Optimum performance of Plant & Machinery:To ensure that Plant & machinery delivers consistent performance throughout the production cycles. Plan the Engineering strategies to improve plant performance & deliver right product at right time & 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.

• Manage Engineering activities in accordance to site procedures:

Engineering documentation shall be in compliance with site procedures and in keeping with cGMP and ISPE guidelines. Execution of the work shall be in compliance with site standards and procedures. Strict cost control and adherence to the procurement policies.

• Interact with cross-functional teams, contractors, and stakeholders to ensure proper reviews and requirements are met:

Complete thorough project design reviews, hazard and quality assessments through cross functional teams. Ensure all project tasks follow site quality and engineering procedures where applicable. Maintain close communication with all project stakeholders by opportunely issuing reports, meeting minutes and action plans.

• Bachelor in Mechanical / Electrical engineering
• 10- 15 years in similar industry

• Should have strong knowledge of Pharma machinery, process machinery and equipment ( OSD, Injectable & Nebulizer ) along with standard utility equipment like Boilers, compressors, HVAC system, water treatment plants: both working principles and maintenance work
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Active leadership role in Start-up, Commissioning, and Qualification phase of the project.
• Experience of working in cross functional teams
• Good project management skills
• Good written communication skills with an emphasis on documenting processes, plant-level analytical test methods, and operating procedures
• Ability to monitor the performance of the manufacturing processes via tracking of key process metrics and to initiate improvement program as required
• To work in concert with Manufacturing and Design Engineering to identify, document, investigate and remedy the cause of product non-conformance.
• Engineering documentation expertise (e.g., P&IDs, User requirement specifications functional specifications, design specifications and protocols)
• Computer skills (MS Word, MS Projects, AutoCAD, MS Excel, MS PowerPoint)
• Problem Solving - Identifies and resolves problems in a timely manner.
• Communication - Strong oral and written communication skills.
• Teamwork - Balances team and individual responsibilities which fosters group commitments to goals and objectives.
• Planning/Organizing - Prioritizes and plans work activities, sets goals and objectives.
• Innovation - Displays original thinking, creativity and resourcefulness which generate innovative approaches and ideas.
• Continuous improvement.
• Energy Management.
• OPEX and CAPEX management
• Timely identification of issues and troubleshooting during manufacturing process
• Commissioning and Qualification