Cleaning Validation Specialist

AMARIS GROUP SA; Singapore; On-site; SGD 60,000 - 85,000; Full time

Benefits offered by this job

International community

Robust training system

Opportunities for sustainability initiatives

Job summary

AMARIS GROUP SA in Singapore is seeking a Cleaning Validation Engineer to lead and support cleaning validation activities in a GMP-regulated environment. You will develop and execute validation strategies, ensure compliance with GMP and GDP requirements, and collaborate with cross-functional teams. Ideal candidates should have a Bachelor's degree in Engineering or Life Sciences and significant experience in cleaning validation within pharmaceutical contexts. The role offers an engaging and supportive work environment with a commitment to diversity and inclusion.

Qualifications

• Strong experience in cleaning validation or cleaning qualification.
• Experience preparing and reviewing cleaning validation protocols.
• Good knowledge of GMP manufacturing equipment and cleaning processes.

Responsibilities

• Lead and support cleaning validation activities.
• Develop, review, and execute cleaning validation strategies.
• Ensure compliance with GMP and GDP requirements.

Skills

Cleaning validation principles

Regulatory expectations

GMP compliance

Cleaning qualification

Leadership skills

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

We are seeking a Cleaning Validation Engineer to lead and support cleaning validation activities for manufacturing equipment and processes within a GMP‑regulated environment. The role involves developing and executing cleaning validation strategies, reviewing validation documentation, supporting risk assessments, and ensuring compliance with GMP, GDP, and data integrity requirements.

Responsibilities

• Lead and support cleaning validation / cleaning qualification activities for manufacturing equipment and processes
• Develop, review, and execute cleaning validation strategies, protocols, and reports
• Lead technical discussions related to cleaning approach, acceptance criteria, sampling strategy, and validation rationale
• Review cleaning procedures, cleaning methods, and equipment cleaning practices
• Support risk assessments related to product carryover, cross‑contamination, equipment design, and cleaning effectiveness
• Define or review acceptance limits, worst‑case product selection, residue limits, and sampling points
• Collaborate closely with Manufacturing, QA, Validation, Engineering, and QC teams
• Ensure documentation is aligned with GMP, GDP, data integrity, and site quality requirements
• Identify gaps in current cleaning validation practices and recommend practical improvement actions
• Support audit readiness and respond to cleaning validation‑related questions during inspections or internal reviews

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field
• Strong experience in cleaning validation or cleaning qualification within pharmaceutical, biotech, or GMP‑regulated manufacturing environments
• Solid understanding of cleaning validation principles, strategies, and regulatory expectations
• Experience preparing and reviewing cleaning validation protocols, reports, risk assessments, and related GMP documentation
• Good knowledge of GMP manufacturing equipment, cleaning processes, and sampling methods such as swab and rinse sampling
• Familiarity with cleaning validation lifecycle management, revalidation activities, and process improvement initiatives
• Exposure to health‑based exposure limits, MACO, PDE/ADE calculations, or worst‑case product selection is preferred
• Ability to work independently and provide technical guidance on cleaning validation topics
• Experience supporting audits, inspections, remediation projects, or acting as a Validation Lead/SME is an advantage
• Exposure to sterile manufacturing, biologics, vaccine, API, or pharmaceutical manufacturing environments is preferred
• Strong leadership, communication, and stakeholder management skills
• Fluent in English, both written and spoken

Benefits

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• Opportunities to contribute to sustainability initiatives through the WeCare Together program, empowered to design and lead projects that create real social or environmental impact

Equal Opportunity Employer. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.