Process Engineer biopharma

Vital Link Solutions; Leinster; On-site; EUR 60,000 - 90,000; Full time

Job summary

Vital Link Solutions seeks a Process Engineer for a 6–9 month contract in Dundalk, Co. Louth, Ireland.

The role focuses on biopharmaceutical manufacturing and covers commissioning, qualification, system execution, and project engineering. The candidate will lead cross-functional teams, manage vendors/contractors, and ensure on-schedule delivery while aligning with EU/international regulatory standards, safety, and Lean Six Sigma practices.

Qualifications

• Degree in Chemical, Biochemical Engineering or related discipline with core bioprocessing fundamentals.
• 3+ years of hands-on process engineering in biopharmaceutical design, construction or start-up.
• Familiarity with EU/international regulatory codes, safety, and Lean Six Sigma experience (desirable).

Responsibilities

• Commissioning & Qualification: Lead cross-functional teams to deliver C&Q requirements and develop lifecycle documents.
• System Execution: Manage installation, start-up, testing to OQ, PQ/PPQ readiness.
• Project Engineering: Drive schedules, work plans, vendor/contractor management, and equipment cost tracking.
• Technical & Compliance: Conduct equipment design reviews and implement regulatory-compliant solutions.

Skills

Project leadership

Vendor management

Cross-functional collaboration

Regulatory awareness

Education

B.Sc./M.Eng in Chemical/Biochemical Engineering

Tools

DCS/PLC/MES automation

Job description

Job Title: Process Engineer (Contract) Location: Dundalk, Co. Louth, Ireland (On-site) Duration: 6–9 Months (Fixed Term)

About the Role

Are you an experienced Process Engineer looking for an impactful, high-visibility contract role in biopharmaceutical manufacturing?

Key Responsibilities

• Commissioning & Qualification: Lead cross-functional teams to deliver C&Q requirements. Develop and review critical lifecycle documents, including Risk/Criticality assessments, URS, FAT, and C&Q documentation.
• System Execution: Manage installation, start-up, and testing of process systems through OQ completion, ensuring post-OQ (PQ/PPQ) readiness.
• Project Engineering: Drive project deliverables such as schedules, work plans, vendor/contractor management, and equipment cost tracking.
• Technical & Compliance: Conduct equipment design reviews, identify critical compliance gaps, and implement technical solutions aligned with international regulatory standards.

What You Bring

• Education: Degree (B.Sc., M.Sc., or M.Eng) in Chemical, Biochemical Engineering, or a related discipline with core bioprocessing fundamentals.
• Experience: 3+ years of hands‑on process engineering experience within biopharmaceutical design, construction, or start‑up environments.
• Technical Expertise: Deep understanding of bulk vaccine operations, sterile filling processes, unit process/utilities, and DCS/PLC/MES automation platforms.
• Project & Team Leadership: Proven success managing vendors/contractors, keeping projects on schedule/budget, and leading teams in matrix environments.
• Standards & Safety: Strong familiarity with EU/International regulatory codes, a solid safety ethos, and Lean Six Sigma experience (desired).