MedPharm
Senior (Lead) Facilities Technician
Durham, NC - Full Time
General Information
Position Summary
The GMP Facility Lead is an onsite role overseeing and coordinating the daily Facility maintenance activities, environmental monitoring and ensuring all facilities equipment maintenance schedules are up to date and maintained to GMP standards. Working alongside the GMP Operations Team and the Facilities Management Team, the GMP Facility Lead will generate the relevant SOP’s and review validation documentation for new and existing facility systems & equipment. The GMP Facilities Lead will ensure that maintenance logbooks, CMMS and GMP documentation is completed to a high compliant standard. The GMP Facilities Lead will also aid in the facilitation of assigned Environmental Health and Safety tasks including but not limited to hazardous waste disposal, wastewater reporting, making recommendations to management regarding compliance with OSHA, EPA and other regulatory agencies and assist in the development of EHS training programs and communication.
Essential Functions
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
| Title: Facilities Lead Technician | Date: March 25, 2025 |
| Site: Stirrup Creek FLSA Status (US Only): | Department: Reporting To: Facilities Mgr |
Position Summary
The GMP Facility Lead is an onsite role overseeing and coordinating the daily Facility maintenance activities, environmental monitoring and ensuring all facilities equipment maintenance schedules are up to date and maintained to GMP standards. Working alongside the GMP Operations Team and the Facilities Management Team, the GMP Facility Lead will generate the relevant SOP’s and review validation documentation for new and existing facility systems & equipment. The GMP Facilities Lead will ensure that maintenance logbooks, CMMS and GMP documentation is completed to a high compliant standard. The GMP Facilities Lead will also aid in the facilitation of assigned Environmental Health and Safety tasks including but not limited to hazardous waste disposal, wastewater reporting, making recommendations to management regarding compliance with OSHA, EPA and other regulatory agencies and assist in the development of EHS training programs and communication.
Essential Functions
- Maintain consistent and document compliance with all relevant Environmental Health and Safety (EHS) systems and functions, Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
- Be the system Owner for the Building Management System.
- Be the system Owner for the Environmental Monitoring System
- Identify KPIs and build business cases to improve the processes and systems in the GMP shared areas
- Act as a point of contact for team members’ queries and escalations with regards to any facility issues within the GMP areas.
- Work with other groups for Facilities requirements relating to quality systems, safety, cGMP areas facility maintenance, cGMP related utilities maintenance & availability, equipment engineering & maintenance, validation, and warehousing for cGMP related materials /product storage.
- Vendor contract oversight
- Perform routine inspections to ensure compliance with regulatory requirements and company EH&S procedures including fire extinguisher inspections, emergency eyewash/safety shower inspections and tests and inspections of hazardous materials accumulation areas
- Provide consultation regarding the management, disposal and documentation of hazardous and regulated waste.
- Relevant Pharmaceutical manufacturing Industry experience within GMP environment 3 years plus.
- Experience or Certifications in HVAC, Low & Medium voltage power, knowledge of plumbing and minor electrical systems
- Experience working with USP and reverse osmosis water systems
- EHS experience, either in a technician or leadership role
- Collaborates well with others; proactively contributes to group objectives and volunteers to help other departments as needed.
- Able to communicate effectively with all levels of management, employees, and outside contacts
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
- Minimal travel required between multiple facilities within a 5-mile radius
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
