EM Analyst

Position Type: Contract

Requirements

• Bachelor's degree in Microbiology, Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline
• Foundational understanding of EU GMP Annex 1, Environmental Monitoring, contamination control, aseptic processing, cleanroom practices, and GMP requirements
• Exposure to Environmental Monitoring programs, including viable/non-viable monitoring, sampling strategies, alert/action levels, data review, and trending
• Familiarity with risk assessment methodologies such as FMEA, HACCP, or risk ranking, with the ability to apply risk-based thinking to GMP and contamination control activities
• Strong written and verbal communication skills with the ability to prepare clear GMP documentation, technical reports, and supporting assessments while collaborating effectively with cross-functional teams
• Familiarity with ISO 14644, CCS, CAPA, or regulatory inspection activities is preferred

Responsibilities

• Support EU GMP Annex 1 gap assessments by reviewing Environmental Monitoring practices, identifying compliance gaps, and assisting with remediation activities
• Assist with Environmental Monitoring program activities, including review of viable and non-viable monitoring data, sampling locations, frequencies, alert/action levels, and EM trends
• Support risk assessments using established methodologies such as FMEA, risk ranking, or HACCP to evaluate contamination risks and provide input into monitoring strategies and mitigation activities
• Prepare and update GMP documentation, including EM program documents, risk assessments, gap assessment reports, CAPAs, SOPs, work instructions, CCS documentation, and trend reports under appropriate guidance and review
• Collaborate with Quality, Microbiology, Manufacturing, and other site teams to support Annex 1 readiness, EM excursion investigations, CAPA activities, audit preparation, and continuous improvement initiatives