Senior Engineer, Facilities And Engineering

Position Summary

The Senior Engineer will provide hands-on technical expertise and leadership across Facilities, Engineering, Validation, Metrology, Capital Projects, Asset Management, and Reliability-Centered Maintenance within a pharmaceutical organization. You will manage complex technical tasks, leading projects, and ensuring compliance with regulatory standards while optimizing operational efficiency and equipment performance.

Responsibilities

• Provide hands-on support for the maintenance, operation, and optimization of facilities, including laboratories, production areas, and office spaces.
• Conduct troubleshooting and repair of facility systems and equipment to ensure performance and compliance with health, safety, and environmental regulations.
• Help implement facility improvement projects and routine maintenance activities.
• Perform hands-on engineering tasks related to the design, installation, and commissioning of systems and equipment.
• Lead troubleshooting efforts for engineering issues, ensuring systems operate.
• Help implement preventive and predictive maintenance programs to enhance system reliability and performance.
• Support the hands-on execution of validation activities for systems, equipment, and processes, ensuring compliance with FDA, EMA, and internal standards.
• Develop validation protocols and documentation, addressing any deviations or issues identified during the process.
• Collaborate with teams to ensure validation outcomes.
• Manage hands-on metrology programs to ensure the accuracy and reliability of measurement systems and instruments.
• Perform calibration and maintenance of measurement systems, ensuring adherence to industry standards and regulatory requirements.
• Conduct regular inspections and adjustments to maintain metrology accuracy and performance.
• Provide hands-on support for capital projects, including the installation, testing, and commissioning of new equipment and systems.
• Help with project planning, documentation, and execution, ensuring projects are completed on time, within budget, and to quality standards.
• Collaborate with other teams and external contractors to achieve project goals and resolve any issues that arise.
• Help develop asset management strategies to maximize the value and lifespan of company assets.
• Perform hands-on tracking, maintenance, and optimization of assets, contributing to the implementation of asset management processes.
• Analyze asset performance data and provide recommendations for improvements and corrective actions.
• Help develop reliability-centered maintenance programs to improve equipment reliability and reduce downtime.
• Analyze maintenance data to identify failure trends and implement RCM practices to improve maintenance activities.
• Help develop maintenance strategies and corrective actions to address reliability issues.
• Prepare and maintain detailed documentation for all activities related to validation, metrology, engineering, capital projects, asset management.
• Produce regular reports on project status, maintenance activities, asset performance, and compliance, ensuring accuracy and adherence to regulatory requirements.
• Ensure that all documentation is up-to-date, and compliant with internal and external standards.
• Ensure all activities comply with regulatory requirements, industry standards, and company policies.
• Help promote safety protocols and emergency response plans, conducting regular safety audits and inspections.
• Address safety issues promptly and ensure adherence to safety and environmental regulations.
• Identify opportunities for process improvements and contribute to projects aimed at enhancing operational effectiveness.
• Stay informed about industry best practices and technological advancements, integrating solutions into operations.
• Foster a culture of continuous improvement within the team.

Education and Experience

• Bachelor's degree in Engineering, Facilities Management, or a related field.
• 5+ years of experience in facilities management, engineering, validation, metrology, capital projects, asset management, and reliability-centered maintenance in a pharmaceutical or regulated industry.
• Technical skills with practical experience in troubleshooting and maintenance of systems and equipment.
• Knowledge of GMP, FDA regulations, and other relevant compliance requirements.

The annual base salary for this position ranges from $126,080 to $157,600. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.