Process Engineering Manager

The process engineering manager is responsible for leading a team that support 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 company standards/policies and industry best practices. Responsible for reliable, efficient and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area. Serve as technical SME on all process-related equipment and mentor junior team members in Good Engineering Practices

Requirements

Lead a team that performs the following responsibilities:

• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
  
• Assist with set-up maintenance for new equipment (incl. spare part needs).
  
• Assist with planning of maintenance / calibration / qualification activities.
  
• 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, Qualification and Validation activities
  
• Develop periodic re-qualification plan
  
• Execute periodic equipment re-qualifications
  
• 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 within a 24/7 GMP environment.
  
• Perform startup and commissioning activities as required.
  
• Support and/or perform investigations / deviations from an engineering 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.
  

Benefits

• PTO 18 days (Company Policy)
  
• Federal 6 days
  
• Employee Healthcare we have four options; one of them we cover 100% for the employee
  
• Life Insurance - Employee policy 100% covered by HCG
  
• Long Term Disability Insurance - Employee policy 100% covered by HCG
  
• 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.
  

We support our diversity, equity, inclusion and belonging efforts because we believe that by cultivating an environment where our diverse employees can share their ideas and thrive, we will be able to better serve our organization and our global customers. Our commitment is that we have an inclusive culture that values each of our employees background, by empowering our staff to feel valued, have a sense of belonging, make positive contributions to the communities in which they live and work, and be proud to be part of Horizon Controls Group.