• Job Description

  Req#: 25-254077
  
  Job Title: Senior Process Engineer
  Pay Rate: *** - ***
  Location: Onsite
  Job Description Summary:
  This individual will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of Commissioning, Qualification and Validation (CQV) activities for facility, utilities and manufacturing equipment.
  Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility.
  Flexible to support extended hours or second shift when needed to ensure the project's critical timeline is maintained.
  
  Major Accountability:
  Guide and supervise onsite installation and CQV activities of equipment/system.
  Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.
  Perform CQV execution as assigned.
  Perform GMP risk assessments (incl. Sensors SRA).
  Provide technical trouble shooting during Startup, PQ and validation activities
  Develop periodic requalification plan
  Execute periodic requalification plan
  Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
  Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
  Write/revise accurate engineering documents for various production system.
  Independently manage and resolve deviations on equipment and systems.
  Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
  Lead complex root cause investigations Performs change assessments Preparing, scheduling, coordinating, and monitoring of assigned engineering projects. Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.
  Second line escalation in case of equipment failures
  Driving continuous improvement from an asset perspective Reducing safety risks through simplification and error proofing machines Improving equipment reliability through equipment design modifications
  Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
  Set-up maintenance for new equipment (incl. spare part needs). Supply information and technical data for securing spare parts.
  Assist with preparation of plans for maintenance / calibration / qualifications.
  Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
  Assist with preparation of estimates for bids and proposals.
  Support internal and external audits.
  Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
  Provide responsive customer support with emphasis on customer satisfaction. Perform startup and commissioning activities as required.
  Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs Complete and provide accurate documentation, as required in cGMP operations.
  Use of CMMS system for documentation of relevant work.
  Other related duties as assigned.
  
  Minimum Requirements:
  Bachelor’s Degree in Engineering or related field is required
  5+ years of relevant experience in a GMP environment is required
  Previous experience in the pharmaceutical industry is required.
  Pharmaceutical aseptic filling experience is preferred Vendor management experience is a plus
  

• About the company

  Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

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