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Equipment Engineer
Equipment EngineerSunrise Systems Inc • Warren, NJ
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Equipment Engineer

Equipment Engineer

Sunrise Systems Inc • Warren, NJ
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Title : Equipment Engineer

Job ID :  25-10876

Location : Warren, NJ 100% onsite

Duration : 12 Months

Work Schedule : Mon-Fri(normal business hours)

Must Have :

  • Bachelor's degree required
  • Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.
  • Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms / Areas).
  • 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.
  • Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments / equipment.
  • Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System.

The duties / responsibilities shall include, but not be limited to the following :

  • 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,n 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 the CMMS system.
  • Modifies or updates 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 -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms / Areas).
  • Manages and trains the calibration technicians. Directs and assists technicians during equipment issues and repairs.
  • Supports multiple sites within Warren.
  • 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 the supplier for a quotation on external calibration / PM of the equipment and calibration standards
  • Initiates, participates, and assists in the resolution of quality investigations.
  • Authors 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.
  • Adheres 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.
  • Approves Change Request, Asset Inductions, and Work Request.
  • Approving 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.
  • Adheres to all safety procedures and hazard communication.
  • May be called upon to act as SME in both internal and regulatory audits.
  • Qualifications :

  • Knowledge of cGMP and good documentation practices.
  • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  • Strong problem-solving skills and the ability to work independently.
  • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
  • Strong multi tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously.
  • Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
  • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and / or Maximo Computerized Maintenance Management System (CMMS) preferred.
  • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups.
  • Required 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 / Mental Demands :

  • Occasional stooping, bending, stretching, pushing, pulling, reaching, and / or lifting up to 25 lbs.
  • Ability to sit, stand, walk, and move within workspace for extended periods.
  • Ability 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.
  • Travel Requirements :

  • Local travel is required for this position to support multiple sites.
  • The hourly rate for this position is between $40-$45 per hour.

    Compensation :

    Factors which may affect starting pay within this range may include [geography / market, skills, education, experience and other qualifications of the successful candidate].

    Benefits :

    Sunrise offers ACA compliant medical coverage / dental insurance / vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

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