Process Manufacturing Engineer — Equipment & NPI Lead

Tandem Project Management Ltd.

Ireland

Remote

EUR 65,000 - 90,000

Full time

14 days+

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Job summary

Tandem Project Management Ltd. in Athlone is seeking a Contract Manufacturing Engineer (Equipment System Owner) to provide technical support to production and maintenance teams in key process systems and manufacturing areas.

The role focuses on ownership of Fill Finish equipment projects, including NPI initiatives, with emphasis on GMP compliance and safety. The ideal candidate has a pharmaceutical/biotech engineering degree and at least 3 years of relevant experience, plus strong

Qualifications

Degree in pharmaceutical, chemical or mechanical engineering or equivalent.
Project management would be a positive.
Minimum of 3 years relevant experience in a technical engineering role in the Pharmaceutical/Biotech industry.
Experience of Aseptic Filling processes would be an advantage.
Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
Experienced in leading and facilitating structured problem solving approaches to resolve equipment/process issues.
Strong technical capabilities, communication skills, teamwork abilities and initiative.
Strong knowledge of regulatory requirements and current Health and Safety Regulations legislation.
Proven ability to work well as part of a team and on own.
Project planning and management experience

Responsibilities

Acts as an advocate for engineering continuous improvement activities.
Take the lead in troubleshooting and problem solving on process equipment while providing coaching and mentoring to other engineering, maintenance and operations staff.
Technical support for new equipment installation and commissioning phases projects.
Being Engineering owner of NPI projects
Ownership of operational readiness activities for process equipment and maintenance such as development of maintenance job plan content, maintenance related procedures, spares identification.
Work closely with other site functions to ensure a smooth transition between project and operational phases.
Design input for new product introduction and related CAPEX projects.
Ownership of process safety and equipment related investigations.
Ownership and delivery of equipment / technical training on process equipment.
Ownership and tracking of engineering KPIs for the process areas.
Encourage and sustain a high safety culture and performance within the maintenance and engineering teams.
Optimization of equipment process design to enable improved turnaround of production equipment.
Plan and manage day-to-day technical support work on process and associated equipment to meet manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and being cost efficient.
Implement equipment and maintenance reliability improvements.
Development and implementation of area / equipment improvement plan to repeat failures and other maintenance problems.
Review of executed maintenance activity and identify improvements to the maintenance job plan content.
Ensure compliance to the company’s Governance standards and Regulatory requirements.