As a Sr. Facilities Specialist, you will play a pivotal role in ensuring the efficient and compliant operation of our manufacturing facilities. Reporting to the Plant Services Manager, you will be responsible for overseeing the maintenance, calibration, and validation of critical equipment and utilities to support pharmaceutical production. This role requires a strong understanding of cGMP regulations, equipment reliability, and a proactive approach to troubleshooting and problem-solving.
- Lead and coordinate maintenance activities for critical manufacturing equipment, ensuring adherence to cGMP standards and regulatory requirements.
- Develop and implement preventive maintenance programs to minimize downtime and ensure equipment reliability.
- Collaborate with cross-functional teams to schedule maintenance activities without compromising production schedules.
Calibration and Validation:
- Manage the calibration and validation programs for equipment and instrumentation to ensure accuracy, precision, and compliance with industry standards.
- Work closely with the Quality Assurance team to address any deviations and implement corrective and preventive actions as needed.
- Oversee the operation and maintenance of utilities such as HVAC, purified water systems, and other critical services.
- Ensure continuous monitoring of utilities to maintain a controlled environment for pharmaceutical production.
- Stay abreast of industry trends, regulatory changes, and best practices to ensure the plant services department operates in compliance with local and international regulations.
- Prepare and participate in regulatory inspections, providing necessary documentation and support.
Problem Solving and Continuous Improvement:
- Investigate and resolve equipment-related issues in a timely manner, implementing corrective actions to prevent reoccurrence.
- Identify opportunities for process improvements and cost savings, driving a culture of continuous improvement within the plant services department.
- Bachelor's degree in Engineering or related field; advanced degree is a plus.
- Minimum of 3-5+ years of experience in a similar role within the pharmaceutical or biotechnology industry.
- Experience with vial washing/filling (process equipment)
- Strong knowledge of cGMP regulations and experience working in a regulated manufacturing environment.
- Proven experience in equipment maintenance, calibration, and validation processes.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments.
- Familiarity with Maximo or other Computerized Maintenance Management Systems (CMMS) is preferred.