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Process Control Lead
Global Biologics Company
- 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.
- 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
- BSc in Engineering or related is preferable.
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