Process Project Engineer

Morgan McKinley; Athlone; On-site; EUR 85,000 - 120,000; Full time

Job summary

Morgan McKinley is seeking an experienced Process Project Engineer to lead major equipment packages for a large-scale capital expansion in oral solid dosage manufacturing. You will oversee end-to-end lifecycle from design and vendor selection through installation, verification, and site integration for cleanroom processing equipment.

Responsibilities include coordinating cross-functional teams, managing budgets and schedules, and ensuring safety and regulatory compliance.

Qualifications

• 6–10+ years leading cross-functional engineering project teams in regulated industries.
• Pharma OSD experience is highly advantageous; biologics or medical devices also considered.
• Experience with equipment validation (VMP/VPL) and FAT/IQ/OQ/PQ.

Responsibilities

• Lead multidisciplinary project teams, vendors, and engineering contractors to deliver cleanroom processing equipment packages.
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• Oversee the full qualification lifecycle (URS, DQ/DR, IQ/OQ/PQ) including FAT/SAT.
• Coordinate interfaces across process, electrical, automation, facilities, IT/OT for utility hookups and P&IDs.
• Manage detailed project timelines, budgets, change controls, and reporting.
• Drive risk management and quality across design, build, and implementation.
• Engage with equipment suppliers; conduct FAT and present updates to stakeholders.

Skills

Project leadership

Lifecycle management

Cross-functional coordination

Budget & schedule control

Risk management

Vendor management

Travel readiness

Pharma/OSD experience

Communication & teamwork

Education

Bachelor's degree in Engineering

Job description

We are seeking an experienced Process Project Engineer to lead major equipment packages for a large-scale capital expansion project. In this role, you will oversee the end-to-end lifecycle-from initial design and vendor selection through installation, verification, and site integration- for oral solid dosage (OSD) manufacturing and cleanroom processing equipment. You will serve as the technical focal point, driving cross-functional alignment, managing vendor performance, and ensuring projects are delivered safely, on schedule, and within budget.

Key Responsibilities

• Project & Team Leadership: Drive multidisciplinary project teams, vendors, and engineering contractors to safely execute cleanroom processing equipment packages (e.g., blending, granulation, tableting, dispensing, and equipment washers/cleaning systems).
• Engineering & Lifecycle Management: Oversee the full qualification lifecycle, including User Requirement Specifications (URS), Engineering Specifications, Design Qualifications (DQ/DR), Design Risk Assessments, and verification activities (FAT, SAT, IQ, OQ, PQ, PV/CV).
• Cross-Functional Coordination: Manage critical interfaces across process, electrical, automation, facilities, utilities, and IT/OT teams to coordinate utility hookups, layout reviews, P&IDs, and operational integration.
• Cost & Schedule Control: Build and track detailed project timelines (Gantt charts) and manage the package budget, change controls, and financial reporting.
• Risk Management & Quality: Proactively identify and mitigate technical and operational risks at every stage of design, build, and implementation.
• Vendor & Stakeholder Engagement: Lead regular review meetings with equipment suppliers, conduct factory acceptance testing (FAT), and present project updates to internal stakeholders.
• Education: Bachelor’s degree in Engineering, Science, or a related technical discipline (or equivalent experience).
• Experience: 6–10+ years leading cross-functional engineering project teams within regulated industries. Prior experience in Pharmaceutical OSD (tableting) manufacturing is highly advantageous; experience in Biologics or Medical Devices will also be considered.
• Core Skills: Proven track record in pharmaceutical capital expansion, equipment validation (VMP/VPL), vendor management, and budget tracking.
• Mobility: Willingness to undertake periodic business travel for vendor FATs and design reviews.
• Key Behaviors: Strong interpersonal and communication skills, adaptability in fast-paced environments, collaborative leadership, and a results-driven, problem-solving mindset.