Commissioning and Qualification Engineer

Vital Link Solutions; Ireland; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Vital Link Solutions in Ballydine, Ireland, seeks a Senior C&Q/DeltaV Engineer to join a major pharma project on a hybrid/site-based schedule.

5–7+ years of GMP C&Q experience and hands-on DeltaV DCS required; pharma/biotech exposure with sterile manufacturing is a plus. You will lead qualification efforts, support validation, and ensure cGMP compliance across APIs and processes.

Qualifications

• Formal degree in engineering or equivalent.
• 5–7+ years of site-based C&Q in GMP environments.
• Hands-on DeltaV DCS application experience.
• Pharma/Biotech exposure with sterile manufacturing C&Q is a plus.
• Solid understanding of cGMP and regulatory validation requirements.

Responsibilities

• C&Q execution: commission and qualify process and lab equipment and API processes.
• DeltaV systems: SME for DeltaV DCS commissioning, loop testing, site testing, OQ completion.
• Design and execute validation studies for large-scale API synthesis and purification; assess change control impact.
• Ensure CGMP compliance with CSV and DDQ teams.
• Prepare and review Validation Master Plans, SOPs, protocols, CAPAs and deviations.
• Apply Lean/LEan Six Sigma to improve efficiency and enable technology transfers.
• Operate with minimal direction and mentor junior engineers.

Skills

C&Q expertise

DeltaV DCS

GMP experience

Mentoring

Education

Bachelor's degree in Mechanical/Chemical Eng

Tools

DeltaV DCS

Job description

HIRING: Senior Commissioning & Qualification (C&Q) / DeltaV Engineer We are seeking an experienced Senior C&Q Engineer (DeltaV / API & Lab Equipment) to join a major pharmaceutical project!

Work Mode: Hybrid / Site-based schedule (5 days a week / as needed)

Eligibility: Based in-country only

Location: Ballydine, Ireland

Duration: Immediate Start - Q1 2028 approx

Interview Process: Remote interview conducted by Hiring Manager & Tech Lead

Key Responsibilities

• C&Q Execution: Commission and qualify various process and laboratory equipment, large-scale API processes, bioreactors, filtration systems, and analytical instruments.
• DeltaV Systems: Act as SME for DeltaV DCS commissioning, loop testing, site testing, and Operational Qualification (OQ) completion.
• Process Validation & Change Control: Design and execute validation studies for large-scale API synthesis and purification processes. Review and assess change control impact on validated states.
• Compliance & Quality: Partner closely with Computer System Validation (CSV) and Digital Data Quality (DDQ) teams to ensure cGMP compliance.
• Technical Documentation: Prepare, review, and approve Validation Master Plans, SOPs, Protocols, CAPAs, change controls, and deviations.
• Process Improvement: Apply Lean / Lean Six Sigma methodologies to drive efficiency, technology transfers, and new product introductions (NPI).
• Autonomy: Highly skilled to operate with minimal work direction, defining C&Q strategy and mentoring junior engineers.

Qualifications & Requirements

• Education: Degree in Mechanical, Chemical Engineering, Computer Science, or equivalent technical degree.
• Experience: 5-7+ years of progressive site-based C&Q experience in a GMP environment.
• Technical Skills: Hands-on DeltaV DCS application experience and formal training.
• Sector Background: Essential Pharma/Biotech experience (Sterile manufacturing C&Q or Spray Drying experience is a major plus!).
• Standards: Solid understanding of cGMPs, SDLC principles, and regulatory validation requirements.