Summary of Position

The Sr. Equipment Technician is responsible for performing highly diverse duties related to GMP manufacturing and other related laboratory equipment including the installation, troubleshooting, repairing, and maintenance of production and facility equipment, in accordance with all related safety, preventive, predictive and productive maintenance systems and GMP requirements.

Key Responsibilities

• Performs tasks, including, but not limited to, mechanical, electrical, pneumatic, hydraulic, and troubleshooting and repair of production equipment and ancillary support equipment to ensure optimal functionality while adhering to cGMPs. Read and interpret equipment manuals and work orders to perform required maintenance and service.
• Troubleshoots and repairs bioprocess equipment and ancillary support equipment. Equipment includes, bioreactors, centrifuges, chromatography systems, incubators, BSCs, controlled temperature units, general laboratory equipment and on occasion building utilities.
• Works within Computerized Maintenance Management Systems (CMMS) to complete preventive maintenance and on-demand work orders.
• Works with and supervises outside contractors to perform routine preventive maintenance and on-demand repairs, ensures documentation provided is complete and accurate.
• Ensures that all work/repairs that are going to be performed are appropriately communicated to system operators and key stakeholders, including timelines and any issues that impact the work area to allow for planning/avoiding disruptions.
• Supports equipment relocations by working closely with end users and outside vendors to minimize impact to operations.
• Submits purchase requisitions in System Applications and Products (SAP) to support equipment repairs.
• Performs preventative maintenance procedures for GMP Manufacturing and Quality Control equipment, including supporting building utilities as well has general laboratory equipment as defined by specific equipment protocols.
• Assists in the performance of calibration activities.
• Performs "On-Call" duties requiring a 1-hour response time to the MacroGenics facilities.
• Supports execution of new equipment validation tests and modification and validation of existing equipment as needed.
• Follows and promotes on-the-job safety expectations, including wearing proper Personal Protective Equipment (PPE) and following cGMP rules and guidelines in all designated areas.
• Complies with all safety regulations and maintain clean and orderly work areas.
• Performs other related duties as assigned by Supervisor.

Qualifications

Education, Credentials & Experience

• High School Diploma or equivalent.
• Six (6) years' experience with GMP related manufacturing and/or laboratory equipment in a biotech or pharmaceutical company.
• Prior experience with the troubleshooting and preventive maintenance of GMP related equipment and utilities.

Knowledge, Skills and Abilities

• Ability to use a variety of hand and power tools, electric meters and material handling equipment in performing duties.
• Proficient with Computerized Maintenance Management Systems (CMMS) .
• Ability to work and interact effectively and professionally with and for others to achieve company goals.
• Understanding of facility/utility systems.
• Ability to react to change in a positive and productive manner.
• Proven system troubleshooting skills.
• Demonstrated ability to work independently with minimum supervision.
• Ability to interpret drawings, such as as-builts, P&ID's and equipment schematics/wiring diagrams.
• Ability to follow written procedures.
• Willingness to work with a "hands-on" approach in project construction, testing, and support
• Proficiency in Microsoft Office applications.
• Regularly lift and/or move up to 25 lbs., occasionally lift and/or move up to 50 lbs.
• Availability for after-hours standby and on-call duties including weekends as needed.

Supervisory Responsibilities:

None

Preferred Qualifications:

• Experience in biotech or pharmaceutical industry operations and maintenance.
• Direct experience with GMP facility operation.
• Knowledge and experience working in a highly regulated function.
• Knowledge and experience working in Blue Mountain and Master Control Software.