Senior Engineer, Facilities and Engineering

Job Summary:

The Senior Engineer – Facilities & Engineering is responsible for leading and managing the technical aspects of facilities maintenance, validation processes, metrology programs, engineering projects, and capital investments within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency.

Key Responsibilities:

Leadership and Oversight:

• Lead technical teams and provide guidance on facilities maintenance, validation activities, metrology practices, engineering solutions, and capital projects.
• Mentor and support junior engineers and technical staff in their professional development.
• Collaborate with cross-functional teams to align engineering and project activities with organizational goals.

Facilities Management:

• Oversee the maintenance and operation of company facilities, including laboratories, production areas, and administrative spaces.
• Develop and implement strategies for facility improvements and upgrades to enhance operational efficiency and compliance.
• Ensure facilities adhere to health, safety, and environmental regulations.

Validation Management:

• Lead the development and execution of validation strategies, protocols, and documentation for systems, equipment, and processes.
• Ensure that validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards.
• Manage complex validation projects, including protocol design, execution, and reporting.

Metrology Oversight:

• Oversee metrology programs to ensure the accuracy and reliability of measurement systems and instruments.
• Develop and implement calibration, maintenance, and inspection programs for critical equipment.
• Ensure metrology practices comply with industry standards and regulatory requirements.

Engineering Leadership:

• Lead engineering projects related to the design, installation, and commissioning of systems and equipment.
• Ensure engineering activities adhere to Good Manufacturing Practices (GMP) and other relevant regulations.
• Develop and implement preventive and predictive maintenance programs to enhance equipment reliability.

Capital Projects Management:

• Manage all aspects of capital projects, including facility upgrades, expansions, and new construction.
• Develop project plans, budgets, and schedules; monitor progress and ensure projects are completed on time and within budget.
• Coordinate with internal stakeholders, external contractors, and vendors to achieve project objectives and compliance.

Documentation and Reporting:

• Prepare and review comprehensive documentation for validation, metrology, engineering, and capital projects.
• Generate detailed reports on project status, validation results, calibration activities, and maintenance work.
• Ensure that documentation is accurate, complete, and compliant with regulatory requirements.

Compliance and Safety:

• Ensure all facilities, systems, and processes comply with regulatory requirements and industry standards.
• Develop and enforce safety protocols and emergency response plans.
• Conduct regular audits and inspections to ensure compliance and address any issues promptly.

Continuous Improvement:

• Identify and implement process improvements to enhance efficiency, reduce costs, and improve system reliability.
• Stay current with industry trends, technological advancements, and regulatory changes to ensure best practices are applied.

Qualifications:

• Bachelor’s degree in Engineering, Facilities Management, or a related field; Master’s degree or MBA preferred.
• 7-10 years of experience in facilities management, 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 complex validation processes, asset management, metrology programs, facilities management, 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.