Mechanical QA/QC Lead at Fohntech Group
Limerick, County Limerick, Ireland -
Full Time


Start Date

Immediate

Expiry Date

30 Nov, 25

Salary

0.0

Posted On

31 Aug, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulated Industry, Codes, Management Skills, Gmp, Documentation

Industry

Mechanical or Industrial Engineering

Description

We are seeking an experienced Mechanical QA/QC Lead to support a large-scale pharmaceutical construction project in Limerick.
The successful candidate will oversee all QA/QC activities related to mechanical systems and ensure that construction works are executed to the highest standards of quality, compliance, and safety.
You will play a key role in ensuring adherence to project specifications, GMP requirements, regulatory codes, and client expectations. Prior experience in pharmaceutical construction projects is essential.

QUALIFICATIONS:

  • Bachelor’s Degree in Mechanical Engineering or related discipline.
  • Minimum 5 years of mechanical QA/QC experience, with at least 2 years in pharmaceutical construction.
  • Strong knowledge of GMP, GEP, ISPE Baseline Guides, and EU/US regulatory expectations.
  • Familiarity with piping codes and standards (e.g., ASME B31.3, ASTM, EN standards).
  • Certified Welding Inspector (CWI), CSWIP, or equivalent desirable.
  • Proficient in interpreting P&IDs, isometrics, HVAC schematics, and installation drawings.

SKILLS AND COMPETENCIES:

  • Proven ability to lead QA/QC teams on complex, fast-paced construction projects.
  • Excellent communication, documentation, and stakeholder management skills.
  • Strong attention to detail and understanding of documentation and compliance in a regulated industry.
Responsibilities
  • Lead mechanical QA/QC efforts across all phases of construction on a live pharmaceutical project.
  • Develop and maintain Mechanical Quality Plans, Inspection & Test Plans (ITPs), and commissioning checklists.
  • Coordinate and supervise inspections and testing of mechanical systems, including piping, HVAC, process equipment, and utilities.
  • Review and verify that mechanical installations comply with cGMP standards, project specifications, and relevant codes.
  • Manage and mentor a team of Mechanical QA/QC Inspectors on-site.
  • Review vendor/supplier quality documentation, welding procedures, and materials certifications.
  • Oversee pressure testing, flushing, cleaning, and pre-commissioning activities.
  • Ensure NCRs (Non-Conformance Reports) are managed, investigated, and closed out appropriately.
  • Interface with client representatives, construction teams, and validation personnel to support seamless handover and system turnover.
  • Support audits, walkdowns, and quality punch list resolution.
  • Prepare and compile turnover packages, quality dossiers, and final documentation for CQV and handover.
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