Job Description

PROJECT ENGINEER  for the latest large greenfield Pharmaceutical Project to be built in Dublin.

 Job Summary: We are seeking an experienced Project Engineer with expertise in clean room process architecture design and installation in large scale greenfield pharmaceutical manufacturing projects. This role adds complexity to the equation by going beyond the needs of people and considers the processes and equipment needed for the manufacture of products in a GMP environment. The candidate will specifically focus on reviewing clean room designs and specifications from the client’s engineering design partner. The role will also liaise with some client sister sites globally to ensure standardisation of design and incorporation of lessons learned. The job requires solid and updated knowledge as well as proven field experience in the design and installation of Class A, B, C, D and CNC graded areas utilizing a modular panel approach.

Key Responsibilities:

Design Review and Approval:

• Clean room system owner.
• Collaborate with the engineering design partner to review and approve system designs.
• Ensure that designs comply with local industry standards, regulations, and project requirements.
• Provide technical guidance and feedback to the design partner to optimize system performance.
• Identification of technical issues and lead resolution of the issue until its closed.
• Lead weekly design review meetings for quality and progress.
• Oversee Engineering Partner during design on the following aspects:

• System design and Installation standards.
• Act as the clean room Interface system owner.
• Clean room coordination and liaison with client Work Package Owners.

Specification Oversight:

• Evaluate and approve specifications, drawings, and calculations provided by the design partner.
• Work closely with the design partner to address any discrepancies or modifications required.
• Verify that specifications align with project objectives and regulatory requirements.

 Project Coordination:

• Accountability for delivery of the package schedule to agreed master programme milestones.
• Ensuring design partner remains on schedule and progressively achieves agreed project deliverables.
• Interface with cross-functional teams, including project managers, architects, and other engineering disciplines, to integrate into the overall project.
• Collaborate with the design partner to resolve design-related issues and ensure alignment with project timelines.
• Maintain detailed documentation of design reviews, approvals, and any modifications made during the project lifecycle.
• Prepare regular reports for project stakeholders, providing updates on design progress, challenges, and solutions.

Compliance and Quality Assurance:

• Ensure that systems adhere to pharmaceutical industry regulations, safety standards, and quality assurance protocols.
• Collaborate with internal and external stakeholders to conduct inspections and audits related to system compliance.
• Conduct code compliance assessments and develop solutions for nonconformance.

Qualifications and Skills:

• Must exhibit a good understanding of cGMP for Aseptic Production areas.
• Bachelor’s degree in Engineering or a related field.
• Proven experience as a Project Engineer, with a focus on design review and approval in pharmaceutical manufacturing plant projects.
• Minimum 5-10 years’ experience in similar role on pharmaceutical projects.
• In-depth knowledge of regulations, and industry standards.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills to work effectively with external design partners and internal teams.
• Experienced with cGMP validation processes.

or email tom@kppm.ie

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