About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.

Position Overview

This role is responsible for supporting the site's contamination control and sterility assurance programme by monitoring microbiological and environmental data, leading investigations and CAPAs, conducting risk assessments, and ensuring GMP compliance. Working closely with cross-functional teams, the incumbent drives contamination control improvements, supports validation activities, and helps maintain product quality and inspection readiness.

Key Responsibilities

Leading as SME for specific subjects as part of the Contamination Control SOP in her/his area of expertise
Conducting risk assessments related to contamination control
Overseeing site activities and performance for contamination control systems in her/his scope of responsibilities
Leading investigation following contamination control failures and proposing corrective and preventive actions (CAPA)
Collaborating with cross-functional teams to ensure product quality
Ensuring presence on the shop floor to oversee practices, identify gaps vs SOP for contamination control
Reviewing data from contamination control monitoring to propose improvements as necessary (from monitoring and trends)
Supporting the preparation of validation protocol and supporting projects related to her/his area of expertise
Perform microbiological trend analysis for environmental monitoring (EM), utilities, personnel monitoring, and contamination control programme
Analyze microbiological investigation data to identify trends, recurring issues, and potential contamination risks
Prepare and present contamination control trend reports, providing meaningful insights and recommendations
Lead or support microbiological investigations, including root cause analysis (RCA), CAPAs, and effectiveness checks

Required Qualifications

Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with the global operating procedures and Quality standards
In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP) relevant to sterility assurance and microbiological control
Communication skills to communicate with a large number of functions (from shopfloor to management) and to present complex subjects
Ability to organize and lead routine investigations with a multi-disciplinary team

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

Contamination Control Specialist (6 months contract)