Senior Equipment Engineer

Job Summary:

The Senior Equipment Engineer is the technical owner of assigned manufacturing equipment. This role is accountable for equipment reliability, compliance, life cycle management, documentation governance, and quality system execution within a GMP-regulated pharmaceutical environment. The position requires a Mechanical Engineering background with strong working knowledge of Electrical systems, PLCs, HMI and motor control technologies including variable frequency drives (VFDs), servo drives, and inverters. The incumbent owns complex troubleshooting, quality records, structured problem-solving, documentation alignment with global standards, and continuous improvement of equipment performance.

Essential Duties and Responsibilities:

•            Equipment Lifecycle Ownership

o            Own assigned equipment throughoutits lifecycle (installation, qualification, operation, maintenance, upgrade,and retirement).

o            Ensure equipment remains in validated state at all times.

o            Maintain full technical understanding of mechanical, electrical, and automation systems.

o            Define and maintain equipment standards and technical specifications.

o            Serve as primary technical point of contact for assigned systems.

•            Reliability & Maintenance Strategy Ownership

o            Own and continuously improve preventive and predictive maintenance strategies.

o            Define PM frequencies based on risk, failure history, and criticality.

o            Analyze MTBF, MTTR, OEE, and downtime trends and implement sustainable improvements.

o            Identify recurring failures and implement systemic corrective actions.

o            Ensure maintenance plans are optimized and aligned with global standards.

•            Advanced Technical Troubleshooting

o            Independently investigate complex mechanical, electrical, PLC, and HMI issues.

o            Interpret and validate electrical schematics, P&IDs, and control logic.

o            Perform structured root cause analysis using A3, 5 Whys, Fishbone, and FMEA.

o            Implement technical corrections under formal change control.

o            Ensure all trouble shooting activities are documented and traceable.

•            GMP Compliance & Quality System Accountability

o            Act as the responsible technical owner for all equipment-related:

▪            Deviations

▪            Change Controls

▪            CAPAs

▪            Risk Assessments

o            Initiate, document, and drive closure of quality records within required timelines.

o            Perform thorough investigations using structured problem-solving tools.

o            Define, implement, and verify effectiveness of corrective and preventive actions.

o            Ensure all changes maintain validated state and regulatory compliance.

o            Provide complete, technically sound, and inspection-ready documentation.

o            Serve as equipment technical owner during internal and external audits.

•            Documentation & Global Standards Alignment

o            Develop, revise, and maintain:

▪            SOPs

▪            SOIs

▪            WIs

o            Ensure all site-level documents align with global engineering standards and corporate procedures.

o            Perform gap assessments when global documents are updated.

o            Initiate and execute change controls required to maintain alignment.

o            Ensure documentation accurately reflects current equipment configuration and validated parameters.

o            Maintain disciplined document version control and training impact assessments.

•            Capital Projects & Equipment Modifications

o            Own technical execution of equipment upgrades and modification projects.

o            Define scope, technical requirements, and risk assessments.

o            Review vendor documentation and ensure alignment with site standards.

o            Execute FAT/SAT/IOQ participation and ensure documentation completeness.

o            Ensure all project-related documentation supports validation and compliance requirements.

Basic Qualifications:

•            Bachelor’s degree in Mechanical Engineering or a related technical field.

•            Min. 5 years of experience as a Maintenance Engineer.

•            Strong experience in GMP-regulated environment.

Preferred Knowledge, Skills and Abilities:

•            Demonstrates full ownership mindset.

•            Advanced root cause analysis capability.

•            Project management skills

•            Ability to interpret complex technical drawings and control logic

•            Strong data-driven decision-making capability

•            Effective communication skills with the ability to collaborate across local and global teams.

•            Proficiency in using software tools such as AutoCAD and/or SolidWorks for creating mechanical schematics and design layouts.

•            Proficiency in SAP or any other CMMS (Computerized Maintenance Management Systems).

•            Experience with continuous improvement methodologies like TPM.

•            Ability to mentor and train junior engineers and technicians.

•            Strategic and analytical mindset with proficiency in managing budgets and resources effectively.

Travel Requirements

•            About 10% of the time.

Physical and Mental Requirements:

•            Ability to work in challenging environments, including areas characterized by heat and dust, as well as in cleanroom settings.

•            Physical endurance, flexibility, visual and hearing ability are required to perform tasks effectively.

•            Willing to support execution of critical tasks beyond normal working hours should the need arise.

•            Committed to lifelong learning to remain abreast of industry trends and new technologies.

•            A team player and ability to work collaboratively with both local and global functions within all levels.

•            Conduct training with confidence, patience, empathy, and motivation.

•            Demonstrates full ownership mindset

•            Makes risk-based technical decisions

•            Maintains high documentation discipline

•            Communicates clearly with QA, Operations, Validation, and Global teams

•            Proactively identifies compliance and reliability risks

•            Drives sustainable, long-term solutions rather than temporary fixes