Specialist/ Senior Specialist- Operational Excellence

Role & responsibilities

• Support Drug Product process engineering teams in execution & documentation of IQ/OQ/PQ activities for new and existing processes and equipment.
• Participate in and support technology transfer (TT) activities, including scale-up, process validation, and commercialization readiness.
• Drive and support Continued Process Verification (CPV), Reject Variance Analysis (RVA) through data analysis, trending, and identification of improvement opportunities.
• Provide support in deviation investigations, root cause analysis, and CAPA implementation to enhance process reliability and compliance.
• Assist in creation, review, and harmonization of Manufacturing Batch Records (MBRs) & electronic MBRs to improve right-first-time execution.
• Support development, review, and standardization of Standard Operating Procedures (SOPs) and related documentation.
• Collaborate with Manufacturing, Quality, and Process Engineering teams to implement process improvements, yield enhancement, and cycle time reduction initiatives.
• Promote adoption of Operational Excellence tools (Lean, Six Sigma, etc.) within Drug Product operations.
• Design and provide training on operation tasks, like those captured in SOPs or work instructions
• Read/interpret SOPs to ensure compliance
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrate strong attention to detail
• Propose and support the projects and programs within the businesses for the identification of improvement levers, setting smart objectives and carrying out Manufacturing Excellence programs.
• Support the execution of improvement projects by promoting use of proven tools and approaches to achieve manufacturing excellence.
• Recommend and implement methods to increase the quality of products and/or services.
• Participate in self-development activities and training others.
• Exhibit safety awareness and safe work practices. Protect employees and visitors by maintaining a safe and clean working environment.
• Work closely in conjunction with other OE Managers in US, EU & IN sites and the Director of OE (US, EU & IN) to implement improvement initiatives.
• Perform other related duties as may be reasonably assigned in the course of business or as requested.

Preferred candidate profile:

Master's degree in Pharma / B. Tech Mechanical engineering or equivalent preferred; Education with a scientific background is highly desired.

• Certified Six sigma green belt preferred
• 7 to 10 + years industrial experience, must have experience in Injectable/Sterile
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Strong technical skills
• Impact and influence skills and strong experience in change management
• Project Management skills
• Ability to lead and respond to changing environment