Automation and Control Enigneer

Job Description

Degree or equivalent in chemical, electrical, controls, or automation engineering
Experience of working within a manufacturing environment.
Technical expertise/ knowledge Control systems (PLC, DCS, PLC, SCADA)

Preferably experience in a Pharmaceutical / Biopharmaceutical or similar manufacturing environment.

In depth technical expertise/ knowledge in several scientific and automation engineering areas which will include a number of the following:-
-Instrumentation (sensors, actuators, PMT)
-Motion and control (invertors, servo)
-Electrical Design (control panel and field wiring)
-IT Infrastructure (network ,firewalls, data storage)
-Manufacturing Execution Systems (Data historians, EBR, OEE, SAP)
-ISA Standards (S95, S88)
-P&ID nomenclature and electrical wiring diagrams
-Communication networks and protocols (serial, Profibus, Ethernet)
-Integration technologies (OPC, XML, BatchML)
-Database knowledge (SQL, Oracle, data warehousing, architecture)
-EHS process and standards (CE, PUWER, HAZOP, CHAZOP)

Broad knowledge and practical experience of computer and application validation (preferably using GAMP methodology), cGMPs, and 21 CFR Part 11 in an FDA regulated environment
Working knowledge and understanding of current Good Manufacturing Practices including Good Documentation Practices
Working knowledge and understanding of EHS Practices with respect to the installation of automated plant.
An appreciation of FDA PAT initiatives and the impact on the Pharma industry
Proven track record in providing automation support and maintenance for instrumentation, automation and controls
Capable of working in multi-disciplinary teams across engineering projects, new product introduction and technology projects.

Job Purpose and Key Responsibilities:

Provide technical expertise and implementation resource for a wide range of manufacturing automation and control systems activities on new and existing pharmaceutical equipment and facilities.
Involved in all aspects of automation, instrumentation and control systems through from concept, system design, and implementation, validation and support transition.

Key Responsibilities

  • Leads improvement and technology projects and lead trouble shooting in response to identified needs.
  • Responsible for identifying technology related risks to project.
  • Would work in cross functional engineering teams, cross functional technical teams within site and cross functional project teams with R&D.
  • Own project teams and automation engineering team
  • Work within standards and operational policies / procedures for the automation systems on site.
  • Ensure all work executed is carried out in compliance with current legislation and policy
  • Provide second level support to the existing automation systems to ensure production targets are met.
  • Identify, develop and implement approved automation system changes to support manufacturing operations
  • Support the implementation of the site automation strategy
  • Identify external uncertainties that may affect their work and plans contingencies.
  • Support the NPI process by providing automation engineering and expertise
  • Keep up to date with technologies to ensure the appropriate solutions are utilised to maximise business benefits
  • Work at all times in line with current EHS legislation and the company policies and procedures to maintain own, team and public safety
  • Collaborate with other teams within and above site, including R&D, COE’s, IT, engineering, production, procurement, QA and validation

Accountability:

Provide a high level of technical expertise to the site in the ongoing support of process engineering, laboratory automation, process analytical and process control technologies. To include but not limited to:-

  • Implement and manage coding standards for software changes under full change control
  • Ensure site documentation is appropriately managed
  • Develop, implement, measure, report and enhance Service Level Agreements with Client departments.
  • Ensure that systems are maintained in a validated state using such approaches as
  • Change Control and Configuration Management
  • Provide second line support as required to client groups in compliance with agreed SLAs
  • Implement and deliver training programmes for plant staff
  • Ensure critical spares coverage and lifecycle investment plans are developed for all automation systems
  • Vendor management including third party project resource and support agreements
  • Contribute to the design and development work in support of equipment selection, installation and validation (including business process change)
  • Provide training for other process or production engineers in the lead expert discipline
  • Assist with the improvement of process control systems and working practices, and improve process capability by working in Partnership with the Site’s New Product Introduction and Technology Group.
  • Deliver measurement and control of Process Analytical Technology (PAT) to understand and predict the impact of variability in excipients, drug substances, environmental conditions, equipment conditions and manual operations on the quality of products produced at the site
  • Provide process automation expertise and lead safety assessments where appropriate e.g. CE, PUWER, HAZOP, CHAZOPS
  • Working to high standards of Quality and Safety in compliance with contemporary industry and internal standards.
  • Identify opportunities to improve manufacturing processes and support continuous improvement activities

 

 
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