Equipment Engineer

Job Description:

Pay Range: $50hr - $53hr

Responsibilities:

Operational Activities:

• Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.
• Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System.
• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
• Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.
• Modifies or update CMMS documentation as required.
• Prepares reports and keeps records on calibration inspection, testing, and repairs.
• Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20C / -80C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).
• Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required.
• Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
• Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards
• Initiates, participates, and assists in resolution of quality investigations.
• uthors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment.
• Supports the development, review and approval of calibration and maintenance plans in site CMMS system.
• Supports the execution of process improvement studies, as required.
• dheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
• Performs inventory of the equipment and/or standards in the labs as required.
• Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
• Participates actively in special projects as required.
• Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas)
• Plans, justify and implement cost reduction small projects.
• Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.)
• Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
• Support the development, review and approval of calibration and maintenance plans in site CMMS system.
• Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.

Inventory Management:

• Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
• pproves Change Request, Asset Inductions, and Work Request.
• pproving Calibration and Maintenance forms.
• Perform Client's investigations.
• Review and approve calibration and maintenance work.

Regulatory Responsibilities:

• Maintains all required Corporate, Facilities and EHS training as required.
• dheres to all safety procedures and hazard communication.
• May be called upon to act as SME in both internal and regulatory audits.

Education And Experience:

• BS in Engineering or Science related discipline preferred.
• Minimum 3 years of experience in FDA-regulated industry.
• Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.)
• Maintenance coordination / planning experience preferred.
• Experience working in a clinical environment preferred.

Working Conditions:
Physical Requirements (Due to the nature of the job):

• Occasional stooping, bending, stretching, pushing, pulling, reaching, and the candidate should be able to lift 20 pounds with assistance.
• bility to sit, stand, walk, and move within workspace for extended periods.
• bility to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling.

Environmental Conditions:

• Environment may include working in office, laboratory, or manufacturing area.
• Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required.
• Working safely and effectively when working alone or working with others will be required.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
• Employees holding this position will be required to perform any other job-related duties as requested by management.

dditional Job Requirements:

• Position Handles Hazardous Materials.