Process Automation Team Leader

A speciality biopharmaceutical company is currently recruiting a Process Automation Team Leader to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

Job Responsibilities:

• Ensuring the effective support and management of the process control systems for the Biotech Manufacturing Facility.
• Providing technical expertise, change management, and administration activities to the process control systems, ensuring ongoing availability, reliability, and compliance.
• Providing specialist knowledge relating to process control and be a subject matter expert.
• Leading, mentoring, and directing the Control Team based at the Reykjavik Facility.
• Being responsible for the availability, performance, and compliance of all industrial control systems across the site.
• Establishing 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, developing, implementing, and maintaining 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, identifying and developing 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, developing and implementing an automation strategy to ensure that Process Control systems are specified, designed, and implemented to meet cGMP, Business and EH&S requirements.
• Directly assisting the Head of Engineering in ensuring that adequate budget (opex and capex) is planned and managed in support of Controls team.
• Planning, resourcing, and executing Process Control projects to improve and maintain compliance.
• Providing expertise and consultancy and, where appropriate, leading activities. This involves strategically influencing stakeholders and indirect reports.
• Identifying and managing internal and external (contract) resources as required to meet agreed team commitments.
• Identifying skills and competency development needs of the Process Controls Team and supporting individuals through knowledge transfer and team development through the company HR processes.
• Managing and supporting equipment vendors as required to ensure that requisite standards are adhered to.
• Effectively contributing 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.

Skills and Requirements:

• Qualification to degree level in a relevant discipline and have experience working within engineering in a Pharmaceutical environment.
• 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.
• Demonstrable project management skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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