My client is an Biophrmaceutical facility in North Dublin hiring a Manufacturing engineer responsible for the delivery of programmes relating to manufacturing systems and technology development including, but not limited to, serialisation, automation improvements, sustainability, engineering systems and operations digitalisation and development to the site.

Responsibilities:

• Lead the implementation of approved site programs focused on manufacturing systems and technology development, covering areas such as serialisation, automation improvements, sustainability, and digitalisation of engineering systems and operations.

• Design, procure, install, commission, and validate manufacturing equipment and processes in compliance with site change control protocols.

• Generate comprehensive lifecycle documentation for equipment and associated systems.

• Design and implement Digital Technologies solutions onsite.

• Develop project documentation including URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, and procedures for Engineering Projects.

• Collaborate extensively with internal/external stakeholders and suppliers to finalize process and equipment designs.

• Coordinate and manage suppliers and contractors during project execution.

• Support Engineering functions including Factory Acceptance Testing, Commissioning, and Qualification.

• Optimize new and existing processes to meet production output targets.

• Act as Subject Matter Expert (SME) for the Engineering department as needed.

• Undertake project work as required by the site Capex programme or additional projects as assigned.

• Ensure all project-related documentation complies with cGMP standards.

Experience:

• NFQ Level 7/8/9 Degree in engineering or equivalent (preference for Automation, Mechatronics, or Mechanical Engineering).

• Minimum of 3 years' experience as an Engineer.

• Experience supporting manufacturing biopharma processes.

• Proficiency in automation industry practices supporting GMP environments and applications.

• Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing, including the ability to implement best practices (GAMP) for ensuring cGMP compliance.

• Experience in the design, procurement, installation, commissioning, and validation of manufacturing equipment and processes.

Skills:

• Excellent written and verbal communication skills, with a track record of interacting effectively with senior stakeholders and executive teams.

• Strong decision-making abilities with the capacity to be assertive when necessary.

• Organizational skills with the ability to prioritize tasks effectively.

• Detail-oriented and self-motivated approach to work.

The Next Step for you:

Should this position be of interest to you please forward your CV to Nuira Esmau from Next Generation Recruitment or alternatively call on the main line on 019609773

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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