Contamination Control Specialist (6 months contract)

No deviation Pte Ltd; Singapore; On-site; SGD 85,000 - 120,000; Full time

Benefits offered by this job

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Shape the Future

Job summary

No deviation Pte Ltd is seeking a highly qualified specialist to support the site's contamination control and sterility assurance programme in a GMP environment. You will monitor microbiological and environmental data, lead investigations, CAPAs, and risk assessments, ensuring product quality and inspection readiness.

Collaborating with cross-functional teams, you will drive improvements, support validation activities, and maintain compliance with global SOPs and regulatory standards, reflecting

Qualifications

• Experience in sterility assurance and microbiological or contamination control within pharmaceutical/biotechnology environments.
• Ability to review documentation, processes and products to ensure GMP compliance.
• In-depth knowledge of regulatory requirements and GMP standards for sterility and microbiological control.
• Strong communication skills across shop floor to management to present complex topics.
• Ability to organize and lead routine investigations with a multi-disciplinary team.

Responsibilities

• Lead as SME for contamination control topics within your area of expertise.
• Conduct risk assessments related to contamination control.
• Oversee site activities and performance for contamination control systems.
• Lead investigations following contamination control failures and propose CAPAs.
• Collaborate with cross-functional teams to ensure product quality.
• Ensure presence on the shop floor to oversee practices and SOP compliance.
• Review contamination control data to propose improvements from monitoring and trends.
• Support validation protocols and related projects in your area of expertise.
• Perform microbiological trend analysis for EM, utilities, and personnel monitoring.
• Analyze microbiological data to identify trends and contamination risks.
• Prepare and present contamination control trend reports with actionable insights.
• Lead or support microbiological investigations, including RCA and effectiveness checks.

Skills

Sterility assurance

Microbiological control

CAPA investigations

GMP knowledge

Cross-functional communication

Job description

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
• 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

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.