EM Analyst

ROLE OVERVIEW We are currently seeking an Environmental Monitoring (EM) Analyst to join a leading organization within the life sciences sector, based in an industry-focused location. This is an exciting opportunity for a motivated professional looking to develop their career in GMP compliance and environmental monitoring within a dynamic and supportive environment. This role offers a platform to gain hands-on experience and contribute to vital contamination control processes.

The position is initially offered on a 6-month basis with a competitive hourly rate of up to $40/hr for the right candidate.

• 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.
• As the EM Analyst you will contribute to continuous improvement initiatives related to contamination control and GMP compliance.

• A Degree or higher level 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.

Joining our client’s team provides you with the opportunity to work within a respected organisation committed to industry excellence. You will gain practical experience in GMP compliance and environmental monitoring, advancing your skills in a collaborative setting. This role also offers competitive pay, potential for future career growth, and the chance to be part of impactful contamination control initiatives.

Key Words:
Environmental Monitoring / GMP compliance / EU GMP Annex 1 / contamination control / aseptic processing / cleanroom practices / risk assessment / FMEA / HACCP / CAPA:

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.