Senior Mechanical QA/QC Engineer – Pharma & Construction

Fohntech Group; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Fohntech Group in Limerick, Ireland seeks a Mechanical QAQC Inspection Engineer to oversee QA across pharma and construction projects. The role emphasizes GMP, GEP, and ISO standards, driving QMS improvements and ensuring regulatory compliance throughout the project lifecycle.

The successful candidate will lead inspections, audits, and CAPAs, coordinating with validation, commissioning, construction, and operations teams while interfacing with regulators and clients.

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• 3–5 years Pharma GMP experience and 3+ years Construction/Infrastructure.
• Solid understanding of GMP manufacturing and industrial construction.
• Hands-on validation, commissioning, and qualification experience.
• Familiarity with FDA, EMA, MHRA, ISO 9001.
• Experience with QMS platforms like TrackWise or MasterControl.
• Proven ability to lead cross-functional quality initiatives.
• Excellent written and verbal communication and stakeholder management.

Responsibilities

• Lead QA activities across pharma and construction projects, ensuring GMP/GEP/ISO compliance.
• Develop, implement, and maintain QMS to meet regulatory requirements.
• Oversee mechanical systems installations (HVAC, piping, pressure vessels) with quality focus.
• Coordinate with engineering, validation, commissioning, construction, and operations teams.
• Audit suppliers/contractors; review QA docs and IQ/OQ/PQ protocols (pharma).
• Lead NC investigations, CAPAs, and root-cause analysis for deviations.
• Ensure materials and equipment are installed and qualified to meet regulatory expectations.
• Participate in project planning, risk assessments, and quality reviews from design to handover.
• Serve as primary quality interface with regulators and client auditors.

Skills

GMP

QA/QC

Pharma

Construction Infra

GEP/ISO9001

QMS

Regulatory Liaison

Team Leadership

Education

B.Sc. Mechanical Eng

Tools

TrackWise

MasterControl

Job description

Fohntech Group in Limerick, Ireland seeks a Mechanical QAQC Inspection Engineer to oversee QA across pharma and construction projects. The role emphasizes GMP, GEP, and ISO standards, driving QMS improvements and ensuring regulatory compliance throughout the project lifecycle.

The successful candidate will lead inspections, audits, and CAPAs, coordinating with validation, commissioning, construction, and operations teams while interfacing with regulators and clients.