Senior Project Engineer

Independent Solutions; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

Independent Solutions in Dundalk, Ireland, seeks an experienced Project Engineer to support commissioning and qualification of a pharmaceutical drug substance and drug product manufacturing facility. This hands-on role sits in a Global Engineering team and requires coordinating cross-functional teams, equipment vendors and SMEs to deliver engineering projects.

You will manage installation, start-up and testing of key equipment through OQ, PQ and PPQ readiness, monitor costs and milestones, and

Qualifications

• BSc, MSc or MEng in Engineering, preferably Chemical Engineering or a related discipline.
• Strong process engineering experience within a manufacturing environment.
• Minimum 8 years of relevant post-graduate engineering experience.
• Proven experience within GMP pharmaceutical manufacturing, process design, commissioning and start-up environments.
• Experience progressing systems through OQ and supporting PQ/PPQ readiness.
• Demonstrated ability to lead or coordinate engineering projects and cross-functional teams.

Responsibilities

• Prepare project deliverables including project schedules, work plans and equipment cost tracking.
• Coordinate project activities across engineering, operations, quality and other key stakeholders.
• Manage installation, start-up and testing of key manufacturing equipment through OQ completion.
• Coordinate with cross-functional teams to ensure systems are ready for PQ and PPQ readiness.
• Monitor project costs, progress, milestones and deliverables and provide regular status updates.
• Support cross-functional project teams to ensure site requirements and stakeholder inputs are incorporated into engineering and design deliverables.
• Liaise with equipment vendors, business partners, SMEs and internal stakeholders to support successful project delivery.
• Support project planning, execution, commissioning and qualification activities within a GMP manufacturing environment.
• Identify project risks, issues and dependencies and support appropriate mitigation actions.
• Provide project leadership and coordination across assigned workstreams.

Skills

GMP manufacturing

Project management

Process engineering

Equipment installation

Vendor management

Cross-functional coordination

OQ/PQ/PPQ

Leadership

Communication skills

Education

BSc/MSc/MEng in Engineering (Chemical Engineering preferred)

Job description

Project Engineer - Pharmaceutical Manufacturing

Location: Dundalk, Ireland

Contract: Initial 12-month contract, estimated for long run min 24 months

Working Pattern: Fully onsite

Travel: Occasional travel may be required for vendor meetings, FATs and project activities

Role Overview

We are seeking an experienced Project Engineer to provide project engineering support for the commissioning and qualification of a pharmaceutical drug substance and drug product manufacturing facility.

The successful candidate will work as part of a Global Engineering team and support the delivery of assigned engineering projects, coordinating cross-functional teams, equipment vendors, technical stakeholders and subject matter experts.

This is a hands-on project engineering role suited to an experienced engineer with strong GMP manufacturing, process engineering, equipment installation and start-up experience.

Key Responsibilities

• Prepare project deliverables including project schedules, work plans and equipment cost tracking.
• Coordinate project activities across engineering, operations, quality and other key stakeholders.
• Manage installation, start-up and testing of key manufacturing equipment through Operational Qualification (OQ) completion.
• Coordinate with cross-functional teams to ensure systems are ready for Performance Qualification (PQ) and Process Performance Qualification (PPQ).
• Monitor project costs, progress, milestones and deliverables and provide regular status updates.
• Support cross-functional project teams to ensure site requirements and stakeholder inputs are incorporated into engineering and design deliverables.
• Liaise with equipment vendors, business partners, SMEs and internal stakeholders to support successful project delivery.
• Support project planning, execution, commissioning and qualification activities within a GMP manufacturing environment.
• Identify project risks, issues and dependencies and support appropriate mitigation actions.
• Provide project leadership and coordination across assigned workstreams.
• Required Experience & Qualifications
• BSc, MSc or MEng in Engineering, preferably Chemical Engineering or a related discipline.
• Strong process engineering experience within a manufacturing environment.
• Minimum 8 years of relevant post-graduate engineering experience.
• Proven experience within GMP pharmaceutical manufacturing, process design, commissioning and start-up environments.
• Experience managing equipment installation, testing and qualification activities.
• Experience progressing systems through OQ and supporting PQ/PPQ readiness.
• Demonstrated ability to lead or coordinate engineering projects and cross-functional teams.
• Strong project planning, organisational and problem-solving skills.
• Excellent communication and presentation skills.
• Ability to work effectively with engineering, operations, quality, vendors and technical SMEs.
• Strong team-player mentality with the ability to work independently when required.
• Pharmaceutical or biopharmaceutical manufacturing experience.
• Experience with drug substance or drug product manufacturing facilities.
• Commissioning and Qualification (C&Q) experience.
• Experience with FAT/SAT and vendor management.
• Experience working within GMP-regulated capital projects.
• Experience working as part of a project engineering team delivering multiple concurrent projects.
• Strong preference for candidates with previous GMP environment experience and experience working within project engineering teams.