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Collins McNicholas

JOB TITLE:  

Process Control Lead

COMPANY:

Global Biologics Company

LOCATION:

Nordics

JOB TYPE:

Permanent

  

KEY RESPONSIBILITIES

  • To ensure effective support and management of the process control systems for the Biotech Manufacturing Facility.
  • To provide technical expertise, change management and administration activities to the process control systems, ensuring ongoing availability, reliability and compliance.
  • To provide specialist knowledge relating to process control and be a subject matter expert.
  • To effectively contribute to the resolution of operational issues, co-ordinating proactive and reactive activities associated with all process control systems equipment ensuring that these occur in accordance within regulatory requirements, site specifications and scheduling requirements.

 

 

JOB DESCRIPTION 

  • Lead, mentor and direct the Control Team based at the Reykjavik Facility.
  • Responsible for the availability, performance and compliance of all industrial control systems across the site.
  • Establish the required processes relating to Process Control Systems across the facility, ensuring compliance with all applicable regulatory standards and industry best practice.
  • Working with the C&Q, Quality and Maintenance functions, develop, implement and maintain a maintenance strategy to ensure that all Process Control Systems, are maintained to meet the associated operational risks in the areas of GMP Compliance, Business and EH&S.
  • As part of strategy development, identify and develop the Process Control competencies across site to support cross functional ways of working where appropriate.
  • Working with the Engineering Leads, C&Q and Quality functions, develop and implement an automation strategy to ensure that Process Control systems are specified, designed and implemented to meet cGMP, Business and EH&S requirements.
  • Directly assist the Head of Engineering in ensuring that adequate budget (opex and capex) is planned and managed in support of Controls team.
  • Plan, resource and execute Process Control projects to improve and maintain compliance. Provide expertise, consultancy and where appropriate lead activities. This involves strategic influencing of stakeholders and indirect reports.
  • Identify and manage internal and external (contract) resources as required to meet agreed team commitments.
  • Identify skills and competency development needs of the Process Controls Team, and support individuals through knowledge transfer and team development through the company HR processes.
  • Manage and support equipment vendors as required to ensure that requisite standards are adhered to

 

EDUCATION AND EXPERIENCE

Education:

  • BSc in Engineering or related is preferable.

Experience:

The role holder should be qualified to degree level in a relevant discipline and have experience working within engineering in a Pharmaceutical environment.

 

Engineering competence, time management, diplomacy, assertiveness, and the ability to work under pressure are also essential.  A positive and pro-active approach is needed to aid resolution of issues. 

 

A detailed technical understanding of process control is essential including:

  • Knowledge of Emerson DeltaV and Siemens PLC’s
  • Knowledge of Process Data Historians & MES solutions
  • Specification of equipment within the GAMP 5 Framework (Control systems and instrumentation)
  • Compliant Management of the Software Lifecycle
  • Maintenance of control systems (hardware and software)
  • Managing capital projects.
  • Management experience forming and leading teams

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