Senior Manager Process Maintenance & Projects

About the Company

Rubicon Research is a pharmaceutical formulations enterprise dedicated to delivering value by developing, manufacturing, and marketing branded specialty and generic prescription medicines. Founded in 1999 initially providing contract formulation development services, the company expanded its manufacturing in Maharashtra, India, offering contract development and manufacturing services for regulated markets. Transitioning towards self-commercialization in 2012, Rubicon has established robust R&D centers in India and Canada, alongside two US FDA-inspected manufacturing facilities in India accredited by international regulators.

As of March 31, 2024, Rubicon and its subsidiaries hold 59 active ANDA approvals and 10 active NDAs by the US FDA. Its commercial and strategic growth involves marketing through subsidiaries and third parties, with an expanding footprint across Australia, UK, Singapore, Saudi Arabia, and UAE. Recognized as the fastest-growing Indian pharmaceutical formulations company between 2022 and 2024 per Frost & Sullivan, Rubicon holds significant market share in the US with robust ANDA approvals and specialty CNS brands after its acquisition of Validus in 2024.

Role Purpose

The Senior Manager - Process Maintenance & Projects will oversee performance-driven technical services for process equipment in oral solid dose and nasal manufacturing blocks, managing building maintenance, project planning, and execution. This leadership position ensures optimal equipment reliability and compliance within a regulatory environment.

Key Responsibilities

• Lead the site engineering and maintenance operations for all process equipment and plant facilities including QC and QA areas.
• Manage and develop the engineering team by allocating timely resources and enhancing their competencies.
• Guide site engineering teams in achieving prompt and effective technical solutions to enhance Overall Equipment Effectiveness (OEE).
• Establish, refine, and implement preventive maintenance SOPs and plans for process equipment and facilities.
• Oversee critical spare parts inventory management and administration of AMC contracts with original equipment manufacturers.
• Troubleshoot and resolve complex issues related to process and facility equipment, ensuring timely and effective decisions.
• Foster strategic vendor partnerships to drive improvements in equipment performance and failure analysis.
• Ensure engineering and maintenance compliance with regulatory, GMP, and safety standards.
• Monitor and manage brownfield plant projects regarding schedule and budget; coordinate with stakeholders to meet project deliverables, including compliance with FAT, SAT, IQ, DQ, and OQ protocols.
• Implement reporting and review mechanisms to track project progress and apply corrective measures as needed.
• Promote a performance-oriented culture within the team through regular monitoring, performance reviews, and constructive feedback.
• Drive the establishment and execution of Total Productive Maintenance (TPM) practices.
• Implement preventive maintenance strategies and root cause analysis (RCA) methodologies effectively.

Qualifications & Requirements

• B.E. or B.Tech degree in Mechanical or Electrical Engineering is mandatory.
• Total professional experience between 15 to 18 years, preferably within maintenance and utility management in the pharmaceutical or related industries.
• Familiarity or prior experience working under regulated industry environments is highly desirable.