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SUMMARY

The Senior Facilities Engineer will be responsible for maintaining the pharmaceutical manufacturing facilities, ensuring compliance with regulatory standards, and optimizing operational efficiency. This role involves conducting equipment investigations and Corrective and Preventive Actions (CAPA), overseeing facility equipment, and preparing for FDA audits.

JOB RESPONSIBILITIES

Equipment Investigation and CAPA:

• Conduct thorough investigations into equipment failures and deviations.

• Implement CAPA processes to address and prevent recurrence of issues.

• Maintain detailed documentation of investigation findings and CAPA actions.

Facilities Equipment Knowledge:

• Oversee the maintenance and operation of HVAC systems, clean rooms, water systems, and other critical facility equipment.

• Ensure equipment is operating efficiently and in compliance with industry standards.

• Develop and implement preventive maintenance schedules.

FDA Audits:

• Prepare for and participate in FDA audits and inspections.

• Ensure all facility operations comply with FDA regulations and guidelines.

• Address audit findings and implement necessary improvements.

Regulatory Compliance:

• Maintain knowledge of current GMP (Good Manufacturing Practices) and regulatory requirements.

• Ensure all facilities and equipment meet regulatory compliance standards.

• Assist in the development and updating of SOPs (Standard Operating Procedures).

Project Management:

• Lead and support facility-related projects, including upgrades and new installations.

• Coordinate with cross-functional teams to ensure project objectives are met on time and within budget.

• Manage project documentation and reporting.

Safety and Environmental Compliance:

• Promote a safe working environment by adhering to safety protocols and regulations.

• Ensure compliance with environmental regulations and standards.

• Conduct regular safety inspections and audits.

QUALIFICATIONS

• Bachelor's degree in Engineering, Facilities Management, or a related field.

• Minimum of 5 years of experience in facility engineering, preferably in the pharmaceutical industry.

• Strong knowledge of GMP, FDA regulations, and CAPA processes.

• Proficiency in managing and maintaining facility equipment.

• Excellent problem-solving and analytical skills.

• Strong communication and documentation abilities.

• Ability to work independently and as part of a team.

Preferred Skills:

• Certification in Facilities Management (e.g., CFM, FMP) or similar qualifications.

• Experience with HVAC, clean room operations, and water systems in a pharmaceutical setting.

• Familiarity with project management methodologies and tools.

Working Conditions:

• May involve working in clean rooms and other controlled environments.

• Availability to respond to emergency situations outside regular working hours.

• Occasional travel may be required.