Senior Microbiology Specialist

About the role

CooperSurgical, a leading fertility and women’s healthcare company, is seeking a Senior Microbiology Specialist to drive equipment qualification, analytical method lifecycle management, and continuous improvement across its laboratory operations. The role will act as a subject‑matter expert for microbiology testing, method validation, and regulatory compliance.

Key responsibilities

• Lead IQ, OQ, and PQ activities for laboratory equipment, including protocol development, execution, and reporting.
• Design, execute, and document analytical method validation, transfer, revalidation, and archiving.
• Provide expert guidance on microbiology assays such as bioburden, sterility, endotoxin, ELISA, and immunochromatography.
• Support lean initiatives (5S, Poka‑Yoke) and drive continuous improvement projects.
• Collaborate with Regulatory Affairs, Quality, and R&D to maintain up‑to‑date documentation and ensure compliance with GMP, GLP, and ISO 17025 standards.
• Act as principal investigator for microbiology laboratory activities and serve as SME during internal and external audits.

Required profile

• University degree in Microbiology, Biotechnology, Biology or related field; Master’s degree in analytical methods or quality is highly desirable.
• Minimum 5 years of experience in highly regulated environments (medical devices or pharmaceutical manufacturing).
• At least 3 years of hands‑on experience with instrument and test method validation.
• Proven experience in analytical method transfer and lifecycle management.
• Fluent English (reading, writing technical reports, speaking).

Required skills

• Microbiology techniques: bioburden, sterility testing, endotoxin, environmental monitoring.
• Assay platforms: ELISA, immunochromatography, spectrophotometric assays, immunoassays.
• Method validation, IQ/OQ/PQ, method transfer, rapid method validation.
• Regulatory knowledge: ISO 17025, EU GMP, FDA, USP, ACS, Ph. Eur, ASTM.
• Laboratory software and documentation practices (GDP, GLP, GMP).