About the job
Our client is seeking a Facilities and Engineering Associate. The successful candidate will support the company’s facilities, which include GMP manufacturing suites, non-GMP laboratories, GMP/non-GMP warehouse space and office space. He or she will be responsible for working with the Facilities and Engineering Manager to ensure appropriate equipment onboarding, calibration, validation and maintenance.
Responsibilities will include:
• Provide engineering support, and assistance for facility operations and site services in regulated cGMP clinical aseptic manufacturing, laboratory and office workspace environments.
• Manage daily vendor, Cal/Maintenance schedules, calibration and maintenance programs and projects for systems including but not limited to HVAC (heating, ventilation & air conditioning), power distribution, steam, chilled water and other facility support systems. This includes both the reactive and preventive maintenance programs and activities.
• Perform onboarding and maintenance for all GMP and non-GMP equipment and systems and ensure they are optimized to support the site’s manufacturing and laboratory operations
• Support vendor management by interfacing with third-party facilities maintenance providers for communication and planning, as well as for technical assistance
• Support technical review and report writing for new equipment qualifications as needed.
• Manage all facility equipment and/or system excursions using the company’s reporting system and the associated deviations and CAPA measures based on sound root cause analysis.
• Provide support for near and long-term capital project planning and execution.
• Provide prompt response to requests and issues from facility occupants, and operations managers, and to equipment and facility alarms.
• Manage facility security and access by assigning appropriate permissions to controlled areas of the facility.
Candidate must possess:
• Great work ethic
• Problem solving skills.
• Willingness to continually learn and develop new skills.
• Ability to communicate work activities to teams and senior leadership.
• Vendor management experience
• Experience with the design and installation of manufacturing, laboratory and administration work areas, or facility support utility systems in a research and development environment
• Ability to present and discuss findings with senior and first level management, colleagues, consultants and non-company officials.
• Possess broad analytical and problem-solving skills.
• Demonstrated computer skills; MS Office Suite (Outlook, Word, Excel and PowerPoint)
• Associates Degree in Mechanical or Chemical Engineering, pharmaceutical technology or related fields or any combination of applicable practical experience
• Thrives in a fast-paced, entrepreneurial, and collaborative environment. Openly shared knowledge/ information needed for a team to accomplish tasks or solve problems