Overview
QC Analytical & Microbiology SME Jobs in Cork, County Cork, Ireland at Blackfield Associates
Title: QC Analytical & Microbiology SME
Company: Blackfield Associates
Location: Cork, County Cork, Ireland
We are working with a pharmaceutical company in Cork seeking a QC Analytical & Microbiology SME to support a large expansion programme.
This is a hands-on role supporting GMP manufacturing readiness, validation activities, and QC laboratory operations across both microbiology and analytical functions.
Key Responsibilities:
Microbiology:
- Lead and execute microbiological method qualification and validation (bioburden, endotoxin, sterility-related methods)
- Support environmental monitoring and contamination control activities
- Contribute to microbiological investigations, deviations, and CAPA resolution
- Author and review microbiology GMP documentation (protocols, reports, SOPs)
Analytical Chemistry:
- Support analytical method transfer and validation activities
- Execute QC testing and provide technical review of validation documentation
- Troubleshoot analytical methods and instrumentation issues
- Support laboratory readiness and system implementation activities
Project Support:
- Work across commissioning, qualification, and process validation phases
- Provide SME input into validation strategies, risk assessments, and lab readiness planning
- Support audits and inspections across both microbiology and analytical disciplines
Requirements
- BSc or MSc in Microbiology, Chemistry, Pharmaceutical Science, or related discipline
- 5+ years GMP pharmaceutical experience
- Strong hands-on QC laboratory experience across microbiology and analytical chemistry
- Experience in method validation and/or method transfer
- Solid understanding of cGMP, data integrity, and regulatory expectations (e.g. 21 CFR Part 11)
- Experience supporting projects such as tech transfer, validation, NPI, or expansion programmes
- Strong problem-solving skills in a regulated laboratory environment
- Right to work in Ireland is essential
