Engineer

Under general supervision, the Engineer provides technical support to manufacturing operations by applying engineering principles to troubleshoot, optimize, and improve processes and equipment. This role involves implementing process optimization strategies, equipment / system modifications, upgrades, replacements, and troubleshooting activities in a regulated pharmaceutical / biotech environment. The engineer ensures compliance with corporate policies, industry standards, GMP requirements, and regulatory guidelines. This position requires flexibility to support non-standard shifts, including nights and weekends, depending on business needs.

Key Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and principles with limited supervision.
• Function as a technical expert for process, equipment, and / or systems during troubleshooting and cross-functional discussions.
• Frequently participate in daily operations to resolve complex issues or ensure schedules are met.
• Monitor manufacturing processes and equipment performance; identify and recommend corrective actions and process optimizations.
• Collaborate with Manufacturing, Maintenance, Utilities, Facilities, QA, Validation, and Process Development teams to define requirements and recommend system modifications.
• Support manufacturing / quality systems such as deviations, CAPAs, equipment qualifications, and process validations.
• Apply scientific expertise, compliance knowledge, and troubleshooting skills to manufacturing operations.
• Organize, analyze, and present interpretation of data and results for operational issues or projects.
• Apply engineering principles to support design and execution of experiments, system modifications, and capital projects.
• Lead or support the implementation of equipment improvement projects.
• Act as SME (Subject Matter Expert) for designated systems regarding design, maintenance, and compliance operations.
• Drive Environmental, Health, and Safety (EHS) compliance within area of responsibility.
• Support deviation investigations, define and implement CAPAs, and ensure equipment reliability within assigned area.
• Develop and track equipment performance metrics (availability, downtime, PM effectiveness, etc.), with focus on improvement opportunities.
• Manage equipment ownership responsibilities in CMMS (approving / closing work orders, PM strategy, spare parts updates, and reliability assessments).

Requirements

Education & Experience Requirements

Required Skills & Competencies

Preferred Qualifications

Benefits

Shift & Work Schedule