Process Engineer

1 month ago

Mayo, Ireland TEAM HORIZON Full time
DescriptionTeam Horizon is seeking a Manufacturing Process Engineer for our client who are a global leader in the biopharmaceutical industry, for their site in Mayo. In your new role you will be responsible for providing technical assistance for equipment/machinery and all aspects of performance around the production and packaging of the client products to customer requirements, FDA, HPRA, EPA and safety standards within budget parameters. This will be achieved by active communication and engagement with many stakeholders outside the BU (i.e., E&T, Validations, QA, Vendors, Contractors, etc.) to achieve the BU goals.

 

 

Why you should apply:

This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.

There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 

What you will be doing:

Assist with the management, engineering, process improvement, equipment reliability, and control system activities.

Identify, plan, schedule, manage and communicate on production related projects to all affected stakeholders.

Implement lean technologies such as standard work, visualisation boards.

Support the BU by developing robust process & systems to ensure delivery of effective quality.

Ensure that line processes, equipment and materials are maintained to deliver consistent, reliable and predictable process performance and product quality.

Develop & implement systems & structure to minimise technical downtime on the line.

Resolve technical issues in an effective & timely manner with the technical team to support operations.

Drive continuous improvement and process efficiency programs, i.e., OEE, OPEX, RCA, RCM and productivity output for the BU.

Manage external vendors and services for equipment and technology in the BU along with the Manufacturing.

Manage the technical documentation, reports, files, logs and records for the BU.

Assist with the trending, monitoring, performance of equipment and the reduction of unplanned downtime.

Help manage, track and monitor the relevant KPIs for the Technical Team.

Assist with the trending, monitoring and reduction of repeat deviations associated with the equipment and technology in the BU. Generate and approve associated change controls and relevant protocols.

Help support the BU during regulatory and compliance audits.

Any other duties as assigned.

 

What you need to apply:

Third level qualification in Mechanical, Electrical or Process Engineering.

Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.

Experience in high volume automation pharmaceutical manufacturing environment.

Excellent documentation skills.

Ability to organize workload and work on own initiative.

Experience: Maximo, One Vault, Quality software systems, working with Microsoft Office (Word, Excel, PowerPoint etc.). 

Experience: years working in a regulated environment.

Experience of working on a team, including strong organisational and time management skills.

Strong ability to evaluate, diagnose and troubleshoot problems.

Flexibility to respond to issues outside normal business hours.

Ability to learn new and different technologies.

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