System Automation Engineer

This position is necessary to support the Sterile Manufacturing Facility computerized systems operation, maintenance, compliance, and administrative needs, as well as monitor the health of the Sterile Manufacturing Pilot Plant facility, that is execution of the Sterile Manufacturing Incursion Process.

The ideal candidate would have knowledge of automated GxP manufacturing systems and a background related to PC systems administration and PLC software and hardware design, implementation, and upkeep. Additionally, the candidate would have experience with network infrastructure, and cyber security to aide in compliance with the IT security provisions.

• Provide systems and data administration across multiple GxP systems (e.g., FMS/DCS, PMS, BRS, CCTV, etc.).
  
  
• Create and maintain system back-up strategy for all computerized systems within Sterile Manufacturing. Perform system / data back-ups on all critical GxP systems on a routine frequency.
  
  
• Provide real-time and historical analysis of GxP and non-GxP DCS trend data.
  
  
• Provide technical support, troubleshooting, and guidance on computerized manufacturing systems for Sterile Manufacturing GMP process equipment, facility, and critical utilities. Interface with sterile manufacturing staff, facilities support staff, and outside OEM equipment vendors to troubleshoot and resolve issues with manufacturing systems (e.g., PC, SCADA, PLC-based manufacturing systems).
  
  
• Provide support on automated and computerized system maintenance, upgrades and capital project activities (e.g., control system augmentation, etc.). Activities may include interaction with vendors and suppliers, performance of engineering evaluations for device selection and calculations for equipment sizing, Factory Acceptance Testing and equipment inspection. Conduct impact analysis for upgrades/patch releases made to computerized systems.
  
  
• Facilitate interaction within the Sterile Operations team, i.e., Manufacturing Operations, Microbiology, Engineering & Validation, and Quality Assurance, as it pertains to computerized systems and facility health, i.e., the Incursion Process.
  
  
• Provide training on new and existing automation/computerized system platforms to ensure colleagues remain up to date with current software platforms any changes in technology investments.
  
  
• Provide validation lifecycle support related to automation and computerized systems to maintain the Sterile Manufacturing GMP process equipment, facility, and critical utilities in a complaint manner. Activities include generation, execution, and review / approval of validation lifecycle documentation / test protocols, as well as engineering study support. Support the development of computerized system commissioning and qualification documentation such as design specifications (SDS, HDS, FDS) and User Requirements Specification (URS).
  
  
• Provide Change Control support related to automation and computerized systems to maintain the Sterile Manufacturing GMP process equipment, facility, and critical utilities in a complaint manner. Activities include generation, execution, and review / approval of change control documentation.
  
  
• Support the planning, design, implementation, configuration, testing, and provide administrative support for new computerized systems e.g., Manufacturing Execution System (MES) i.e., e-Logs.
  
  
• Support the design, configuration, and maintenance of closed-circuit TV camera system (ExacqVision CCTV system).
  
  
• Support digital technology advancements with the goal of achieving efficient and consistent data workflows and compliance expectations.
  
  
• Provide technical support related to IT initiatives such as OT Security, GEO Segmentation, etc., as it pertains to Sterile Manufacturing systems and facilities, to ensure compliance with clients data security and integrity requirements.
  
  
• Ensure that technology components are appropriately architected and supported.
  
  
• Execution of Incursion & FMS/DCS Alarm Review Process (per local Incursion SOP):
  

Perform routine monitoring and trending of critical environmental and utility parameters via FMS/DCS (or equivalent system).

Generate Incursion Reports to assess and document product quality and/or facility impact as a result of environmental excursions (e.g., temperature exceeds action alarm limit).

Maintain Incursion log / tracking spreadsheet.

Perform critical and incursion alarm reviews on a weekly basis and during a clinical batch.

Perform weekly reviews of FMS/DCS audit report to confirm appropriate parameter settings.

Perform critical parameter setting reviews as required (e.g., following shutdown of FMC PLC)

Archive reviewed reports per local records retention policy.

Provide incursion data metrics upon request.

• Support the preparation of Standard Operating Procedures (SOPs) related to the Incursion process as well as automated & computerized systems.
  
  
• Support quality deviations: provide input to the investigation team to determine root cause of deviations and identify effective CAPA s to prevent future occurrences.
  
  
• Participate in and/or support safety risk assessments on Sterile Manufacturing equipment and associated sterile manufacturing processes; participate in safety incident root cause investigations.
  
  
• Provide support during internal audits and inspections. Participate in local Management Monitoring program.
  
  
• Collaborate with Management on process improvement initiatives to increase overall process efficiency; identify cost savings opportunities and opportunities to optimize existing processes.
  
  
• Collaborate with the Sterile Team to deploy new technologies and initiatives that align with clients pipeline ambitions.
  
  
• Participate in clinical Sterile Manufacturing operations, as requested.
  

Requirements

• Bachelor of Science Degree in Engineering or Computer Science, or equivalent experience in a relevant technical role.
  
• 5+ years experience working within pharmaceutical industry working with equipment, utility systems and/or facilities.
  
• General knowledge of global GMP regulations related to biopharmaceutical processing / aseptic manufacturing (i.e., FDA 21 CFR Parts 210 & 211; EU GMP Annex 1).
  
• General knowledge of computerized systems (e.g., PC, SCADA, PLC-based systems, etc.).
  
• General knowledge of Computer System Validation regulations and guidance (FDA 21 CFR Part 11, ISPE GAMP 5, EU Annex 11).
  
• General knowledge of Biopharmaceutical systems processing logic, process instrumentation, Programmable Logic Controllers (PLC) and Distributed Control Systems (DCS).
  
• Experience implementing, operating, and developing maintenance procedures for instrumentation and control systems (e.g., Allen Bradley PLC hardware and software).
  
• Experience with administration of PC-based Windows OS computer systems and PLC-based systems, including the daily operational support, troubleshooting and problem resolution.
  
• Experience with networked automation systems and the ability to support such systems to improve system reliability.
  
• Experience with development of functional and design specification documentation.
  
• Experience related to systems qualification / validation in a GMP environment.
  
• Experience with change control / change management in a GMP environment.
  
• Must demonstrate on a consistent basis a transparent and open communication style and collaborative work ethic. Due to the nature of the products and processes supported, this role requires the highest degree of professional ethics and personal integrity.
  
• Must be able to establish effective working relationships both with the Sterile operations staff and our internal & external business partners (i.e., contracted facilities support staff, Microbiology, and QA groups).
  
• Must be able to work in a complex, multi-tasking environment.
  
• Must have the ability to work across local and functional boundaries.
  
• Must be able to effectively manage and prioritize workload within a constantly changing clinical manufacturing environment, while consistently meeting business commitments.
  
• Excellent written and oral communication skills.
  
• Proficient in MS Office applications (e.g., MS Word, MS Excel, MS Project, etc.).
  
• Project management experience 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
  
• 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.