Microbiology Manager

Valtera Group Ltd

Galway

Hybrid

EUR 90,000 - 120,000

Full time

4 days ago
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Benefits offered by this job

Remote work flexibility

Job summary

Valtera Group Ltd is seeking a Microbiology Team Lead for our Galway site in Ireland with remote flex. The role focuses on investigations, projects, equipment qualification, and team leadership within sterile pharmaceuticals/biologics manufacturing.

You will oversee microbiology investigations, support equipment and automation projects, and provide leadership to Level III microbiology personnel, ensuring compliance with GMP and Annex 1.

Qualifications

  • 7+ years of microbiology experience in sterile pharma/biologics manufacturing
  • Proven track record leading microbiology investigations end-to-end
  • Experience at Team Lead/Senior Microbiologist level (even without direct reports)
  • Strong understanding of sterile manufacturing and Annex 1 expectations
  • Experience with media fills and equipment qualification (IQ/OQ/PQ) and GMP documentation
  • Excellent stakeholder engagement and communication skills
  • Ability to balance operational priorities with improvement initiatives

Responsibilities

  • Lead microbiology investigations from initiation through closure
  • Drive root cause analysis and impact assessments
  • Coordinate laboratory projects and automation initiatives
  • Manage equipment qualification activities (IQ/OQ/PQ) and related GMP docs
  • Collaborate with QA, Technical Services and Manufacturing
  • Run Tier 1 meetings and track progress
  • Support Annex 1 compliance activities
  • Mentor microbiology technicians

Skills

Leadership
Investigations
Environmental monitoring
Annex 1 knowledge
Root cause analysis
Stakeholder engagement
Communication
Project management

Education

Bachelor's degree in Microbiology

Tools

IQ/OQ/PQ documentation
GMP documentation

Job description

Microbiology Team Lead

Galway, Ireland (some remote flex)

Permanent Position

Focus: Investigations, Projects, Equipment Qualification & Team Leadership

Sterile Pharmaceuticals / Biologics

Role Context

An exciting opportunity for a senior microbiology professional with 7+ years' experience in sterile pharmaceutical or biologics manufacturing to join a major sterile manufacturing site as Team Lead, responsible for Projects & Investigations.

You will lead microbiology investigations, support equipment and automation projects, and provide leadership to Level III microbiology personnel.

What You Will Do
  • Lead microbiology investigations from initiation through closure
  • Drive robust root cause analysis and impact assessments
  • Support and coordinate laboratory projects and automation initiatives
  • Manage equipment qualification activities including IQ/OQ/PQ documentation
  • Work with vendors, QA, Technical Services and Manufacturing stakeholders
  • Run Tier 1 operational meetings and track investigation/project progress
  • Support Annex 1 compliance activities
  • Prioritise multiple workstreams across a busy GMP laboratory
  • Mentor and support technicians within the microbiology team
What We're Looking For
  • Degree in Microbiology, Pharmaceutical Sciences or related discipline
  • 7+ years' microbiology experience within pharmaceutical, biopharmaceutical or biologics manufacturing
  • Proven track record leading microbiology investigations end-to-end, not just contributing to them
  • Prior experience operating at Team Lead, Senior Microbiologist or equivalent level (even without formal direct reports)
  • Strong understanding of sterile manufacturing, environmental monitoring and Annex 1 expectations
  • Experience with media fills, equipment qualification (IQ/OQ/PQ) and GMP documentation
  • Excellent stakeholder engagement and communication skills
  • Ability to balance operational priorities with improvement initiatives
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