Mechanical QAQC Inspection Engineer

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

Limerick, Ireland | Posted on 02/24/2026

We are seeking an experienced Mechanical QAQC Inspection Engineer with a robust background in Mechanical Engineering, and a proven track record in both the Pharmaceutical and Construction sectors. This is a unique cross-industry role requiring a deep understanding of GMP, GEP, and engineering best practices to oversee and enhance quality processes throughout the project lifecycle.

Key Responsibilities

• Lead QA activities across pharma and construction projects, ensuring compliance with GMP, GEP, ISO standards, and other applicable regulations.
• Develop, implement, and maintain Quality Management Systems (QMS) to ensure adherence to project, client, and regulatory requirements.
• Oversee mechanical system installations (e.g., HVAC, piping, pressure vessels) with a focus on quality and compliance in both cleanroom and construction environments.
• Coordinate with multidisciplinary teams including engineering, validation, commissioning, construction, and operations to align quality standards.
• Perform supplier and contractor audits, review quality documentation, and ensure proper IQ/OQ/PQ protocols are followed (in pharma).
• Lead Non-Conformance (NC) investigations, CAPAs, and root cause analysis for deviations in construction or pharma environments.
• Ensure all materials, equipment, and systems used in construction or manufacturing are installed and qualified to meet regulatory expectations.
• Participate in project planning, risk assessments, and quality reviews from design through handover phases.
• Serve as the primary quality interface with regulatory bodies and client auditors.

Required Qualifications & Experience

• Bachelor’s degree (or higher) in Mechanical Engineering.
• QA experience, with at least 3-5 years in Pharma (GMP environment) and 3+ years in Construction/Infrastructure.
• Solid understanding of mechanical systems within GMP manufacturing and industrial construction.
• Hands-on experience with validation, commissioning, and qualification processes.
• Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001.
• Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl).
• Proven experience in managing teams and leading cross-functional quality initiatives.
• Excellent written and verbal communication, reporting, and stakeholder management skills.