Engineer, Facilities and Engineering

Job Summary:

The Engineer – Facilities & Engineering is responsible for various technical aspects of facilities maintenance, validation activities, engineering projects, and mid-size capital investments within a pharmaceutical organization. This role involves providing technical input, overseeing facility and engineering related projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency.

Key Responsibilities:

• Lead cross-functional teams supporting facilities maintenance, validation, metrology, engineering solutions, and capital projects.

• Oversee facilities operations across labs, manufacturing, and GMP spaces, driving improvements while ensuring health, safety, environmental, and regulatory compliance.

• Lead validation strategies, protocols, and documentation for systems and equipment, ensuring compliance with FDA/EMA requirements.

• Oversee metrology programs, including calibration, inspection, and measurement system accuracy, while maintaining industry compliance.

• Lead corrective maintenance, engineering projects, and preventive/predictive maintenance initiatives in accordance with GMP requirements.

• Manage capital projects (upgrades, expansions, and new installations), including planning, budgets, schedules, and execution.

• Prepare and review validation, metrology, engineering, and capital project documentation and generate project status reports.

• Conduct audits, enforce safety protocols, and ensure compliance with regulatory and quality standards.

• Drive continuous improvement initiatives to enhance efficiency, reliability, and cost-effectiveness while staying current with industry and regulatory trends.

Qualifications:

• Bachelor’s degree in Engineering, Facilities Management, or a related field; Master’s degree preferred.

• 4-6 years of experience in facilities, validation, metrology, engineering, and capital projects, with significant experience in a pharmaceutical or regulated industry.

• Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.

• Proven experience in leading mid-size validation processes, asset management, metrology programs, facilities, engineering projects, and capital investments.

• Strong project management skills with experience in budgeting, scheduling, and resource allocation.

• Excellent analytical, problem-solving, and communication skills.

• Ability to manage multiple priorities and work effectively under pressure.

Working Conditions:

• Office and on-site facilities environment, with occasional travel to various company sites or off-site locations.

• May require occasional evening or weekend work to address urgent issues or project needs.