20 Firstfield Road Gaithersburg, MD 20878
Facility Specialist -
We are seeking a Facility Technician to execute mechanical and maintenance activities in GMP and non-GMP environments in compliance with applicable GMP standards, regulations, techniques and best practices. This position will also be expected to assist in the implementation of processes, procedures and work practices leading to consistent, efficient, and compliant maintenance activities.
Responsibilities include but are not limited to:
- Ensure timely completion of Facility work orders.
- Ensure documentation relating to equipment repair and maintenance is properly completed, submitted in a timely manner, and follows Good Documentation Practices.
- Perform hands-on troubleshooting and maintenance of mechanical and utility systems in GMP manufacturing and laboratory environments, including HVACs, pneumatic/vacuum systems, chillers, compressors, purified water systems, water source heat pumps, and compressed gases.
- Where self-performance of maintenance activities is not feasible, schedule activities with established contractors.
- Ensure contractor work is performed in compliance with SOPs and established work practices.
- Ensure multiple facilities are well-maintained by performing routine facility and utility inspections and reporting inspection results. Initiate and track-to-completion identified corrective actions with minimal supervision.
- Perform minor facilities maintenance task such as patching, painting, and minor plumbing.
- Maintain spare parts inventories for building equipment and utilities.
- Apply best GMP work-practices and techniques to ensure compliance with FDA regulatory requirements.
- Immediately escalate and report any deviations of materials, facilities, processes or procedures to the department head.
- Conduct all activities in the most careful and safe manner and in full compliance with Environmental, Health and Safety requirements.
- Ensure that at all times, equipment, facilities, and materials used in the area of responsibility comply with defined standards.
- Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting.
- To undertake any other duties as requested by the line manager in accordance with company requirements.
- This job can include night, weekend, and on-call hours.
- High school diploma plus additional training in mechanical, electrical, or other relevant technical fields.
- Experience with a computerized asset management system, preferably Blue Mountain Regulatory Asset Management System.
- Minimum of 10 years experience in building and utility equipment maintenance, preferably in GMP pharmaceutical, biotechnology, or related industry.
- Experience working within a quality management system.
- Ability to work independently with minimal supervision.
- Experienced with Good Documentation Practices.
- Excellent organizational, communication, and teamwork skills.
- Ability to document activities and keep organized records.