Senior Validation Engineer – Cleaning & Process Validation

MANTU INTERNATIONAL PTE LTD; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Amaris Consulting’s Life Sciences team in Singapore seeks a seasoned validator to lead cleaning and process validation activities. You will plan, execute, and report validation efforts, working closely with Manufacturing, Engineering, and Quality to meet GMP requirements.

Ideal candidates have 5+ years in pharmaceutical/biotech validation, with experience in both cleaning and process validation, and strong documentation and communication skills.

Qualifications

• 5+ years of validation experience in pharmaceutical/biotechnology environments, with cleaning and process validation experience.
• Fluent in English, both written and spoken.
• Strong analytical, problem-solving, communication, and documentation skills.
• Experience preparing, executing, and reviewing validation protocols and reports.

Responsibilities

• Plan and execute cleaning validation and process validation activities
• Prepare and review validation protocols, reports, and supporting documentation
• Define validation approaches, acceptance criteria, and sampling plans with technical and quality teams
• Coordinate validation execution, including sampling, testing, and documentation
• Review and assess validation results against established acceptance criteria
• Investigate validation deviations and support CAPAs
• Assess impact of changes on validated processes and cleaning procedures
• Provide technical guidance on validation activities and support resolution of validation issues
• Ensure validation documentation is complete, accurate, and GMP-compliant

Skills

Validation experience

Cross-functional collaboration

Documentation

English fluency

Education

Diploma or Bachelor's in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology or related

Job description

Job description

You’ll have the opportunity to work within our Life Sciences team at Amaris Consulting, supporting cleaning validation and process validation activities. You will contribute to validation planning, execution, and reporting, working closely with Manufacturing, Engineering, and Quality teams to ensure activities meet applicable procedures and GMP requirements.

ABOUT THE JOB

• Plan and execute cleaning validation and process validation activities
• Prepare and review validation protocols, reports, and supporting documentation
• Define validation approaches, acceptance criteria, and sampling plans in collaboration with relevant technical and quality teams
• Coordinate validation execution, including sampling, testing, and documentation activities
• Review and assess validation results against established acceptance criteria
• Investigate validation deviations and support root-cause analysis and corrective and preventive actions (CAPAs)
• Assess the impact of changes on validated processes and cleaning procedures
• Provide technical guidance on validation activities and support the resolution of validation issues
• Ensure validation documentation is complete, accurate, and compliant with applicable site procedures and GMP requirements

ABOUT YOU

• Diploma or Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related discipline
• At least 5 years of experience in validation within pharmaceutical or biotechnology environments, with experience in both cleaning validation and process validation
• Experience preparing, executing, and reviewing validation protocols and reports
• Knowledge of cleaning validation principles, including residue limits, sampling approaches, and acceptance criteria
• Understanding of process validation principles and the maintenance of a validated state
• Experience supporting deviations, CAPAs, and change-control activities
• Ability to coordinate validation activities and provide technical guidance to cross-functional teams
• Strong analytical, problem-solving, communication, and documentation skills
• Fluent in English, both written and spoken

WHY AMARIS?

• 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.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Who are we?

Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.