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The Process Engineer II is responsible for support in execution of engineering processes/activities within an aseptic environment (design, implementation, maintenance, etc.) by providing a technical area of expertise while using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives in accordance with the law, internal regulations. Responsible for reliable, efficient, and sustained operation of the facility and all equipment. Additionally, they will support current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.

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  Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
  
• Set-up maintenance for new equipment (incl. spare part needs).
  
• 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.
  
• Create/Execute DQ, IQ and OQ protocols and reports.
  
• Perform GMP risk assessments (incl. Sensors SRA).
  
• Independently manage and resolve deviations on equipment and systems.
  
• Support internal and external audits.
  
• Provide technical trouble shooting during Startup, PQ and validation activities.
  
• Develop/execute periodic re-qualification plan.
  
• Utilize automation (Scada/PLCs /Control Networks hardware) for data gathering and equipment optimization opportunities.
  
• Assist in troubleshooting of process / plant equipment including isolators, filling line and utilities.
  
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
  
• Write/revise accurate engineering documents for various production systems.
  
• Supply information and technical data for securing spare parts.
  
• 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.
  
• Other related duties as assigned.
  
• Use of CMMS system for documentation of relevant work.

Requirements

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 3+ years’ experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
  
• OR Associates Degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with 5+ years’ work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry.
  
• Experience in Project Engineer or Maintenance experience in a GMP plant
  
• Proven skills in project management and problem solving
  
• Exceptional time management, planning, organizational, negotiating and influencing skills
  
• Highly self-motivated with a willingness to assume responsibilities, take ownership for work
  
• Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
  
• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) and similar GMP systems.
  
• Ability to climb ladders and lift up to 50 lbs.
  
• Aseptic Filling line, packaging operation experience is preferred.
  
• Training in radio-chemistry or radio pharmacy is preferred.
  
• Radiation safety education is preferred.

Benefits

• PTO – 18 days (Company Policy)
  
• Federal – 6 days
  
• Employee Healthcare – we have four options; one of them we cover 100% for the employee
  
• Identity Theft Insurance – Employee policy 100% covered by HCG
  
• 401K – with a company match of up to 3.5%
  
• HCG also offer 401K Profit Sharing
  
• HCG Technical - Company laptop provided if needed
  
• HCG brand items – Clothing, stationery, quarterly care packs etc.