Job Title- Integrated Manufacturing Systems Engineer

Location: Goa Site, Verna Industrial Estate, Salcete, Goa, India.

About the job

The Maintenance & Reliability Specialist plays a critical role in ensuring optimal plant performance and equipment reliability within Sanofi's pharmaceutical manufacturing environment. This position is responsible for driving maintenance excellence, implementing predictive maintenance strategies, and ensuring compliance with stringent regulatory standards including cGMP, GXP, and GDP. The specialist will leverage technical expertise, data analytics, and reliability engineering principles to maximize equipment uptime, minimize unplanned downtime, and support continuous improvement initiatives that directly impact product quality and patient safety.

Main responsibilities

• Overall plant reliability – Ensure optimal performance and availability of equipment, utilities, and facilities across the manufacturing site.
• Monitoring of M&R value, performance, and cost effectiveness – Track key reliability metrics, analyze performance trends, and optimize maintenance expenditure.
• Maintenance strategy and continuous optimization – Develop, implement, and refine maintenance strategies to enhance equipment reliability and operational efficiency.
• Reliability technology – Deploy and manage predictive maintenance (PdM) tools, data analytics platforms, and digital work order (WO) systems.
• Spare parts inventory optimization – Manage criticality assessment, stocking levels, and failure effect (FE) analysis to ensure parts availability while minimizing inventory costs.

KEY INVOLVEMENT IN DECISION-MAKING PROCESS

• Direct responsibility for maintenance team staffing decisions, resource allocation, and performance management
• Lead RCA investigations and determine corrective actions for equipment failures
• Provide expert input and recommendations on reliability methodologies and improvement processes
• Contribute to the identification and ranking of reliability engineering and continuous improvement projects
• Offer technical guidance on reliability considerations for capital projects and equipment modifications

LOCAL SPECIFICITIES / KEY RESPONSIBILITIES

Equipment Maintenance & Reliability

• Maintain all process machinery installed in Production and Service Floor areas
• Execute comprehensive Preventive Maintenance programs to ensure equipment upkeep and optimal performance
• Apply advanced technical skills to diagnose issues and minimize machine downtime during breakdown situations
• Conduct Installation Qualification (IQ) and Operational Qualification (OQ) for newly installed equipment
• Perform requalification activities for existing machines following upgrades or modifications

Technical Documentation & Analysis

• Read, interpret, and work with engineering and electrical drawings related to machine components and systems
• Create and maintain comprehensive lists of critical spare parts consumed during maintenance activities to ensure adequate stock levels
• Update equipment history cards following major spare part replacements and significant maintenance interventions
• Maintain accurate records of all maintenance activities and equipment modifications.

Installation & Modification Projects

• Actively participate in machine installation and relocation projects on production and service floors
• Execute modifications to support process optimization and simplification initiatives
• Provide technical input for machine part improvements to enhance overall equipment performance
• Assist in Qualification of any new Equipment/Modification: make URS, IQ/OQ protocol and reports.
• Ensure equipment qualification is as per GMP standards and User requirements along with supporting department.

Installation & Modification Projects

• Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
• Take suggestion from associates to improve the work conditions with great safety and zero risk.
• Periodic review of the implemented procedures and evaluation of the same.
• Train people on safety and their job to ensure zero LTI and IWLT at workplace.
• Implement and maintain Lockout/Tagout (LOTO) procedures for mechanical and electrical equipment, ensuring proper documentation
• Ensure strict adherence to cGMP, GXP, and GDP requirements related to quality compliance
• Initiate and manage HSE work permits before commencing Height Work, Hot Work, or Confined Space Work activities
• Follow Good Housekeeping Practices upon completion of all maintenance activities
• Maintain a strong safety culture and promote safe working practices across all maintenance operations

Quality Compliance activities

• Always Ensure Audit readiness for the Site by following the procedures laid in effective SOPs.
• Ensure completion and implementation of compliance activities in engineering i.e., deviation investigation, CAPA implementation. Regulatory audit handling and CAPA implementation of the same.
• Ensure to coordinate with Quality Assurance for implementation of Corrective actions and preventive actions for Quality events.
• Change Control management: Logging of change control and ensure to close the same after completion of activity in defined time.
• SOP revision for routine revision and Inclusion of corrective actions and preventive actions.

 Training and Development

• Confirm that you are trained on relevant SOP’s before proceeding for execution of the activity.
• Train and help subordinate to implement GMP/HSE systems and development of people.
• Ensure all the new joiners are trained on the job before assigning them the job.

About you

·     Experience: Preferably 3-5 Years

·     Soft skills: MS Word, Excel, SAP, Power point, Presentation skill

·     Technical skills: Specialist in maintenance & reliability.

·     Education: Bachelor’s degree in engineering (Mechanical)

·     Languages: Must know English and able to write and communicate in English

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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