Amaris Consulting

Cleaning Validation Specialist

Amaris Consulting

Singapore · Full Time

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Experience
Any
Salary
Openings
1
Posted
1 અઠવાડિયું પેહલા
Work mode
In office
Education
Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences or related
Resume
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Where you'll work

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Job description

About the Role

We are looking for a Cleaning Validation Specialist to take charge of and assist in cleaning validation procedures for manufacturing equipment and processes within a GMP-compliant setting. This position requires developing and implementing cleaning validation plans, critically assessing documentation, performing risk analyses, and assuring adherence to GMP, GDP, and data integrity standards.

Key Responsibilities

  • Lead and support cleaning validation and qualification processes across manufacturing equipment and protocols.
  • Develop, evaluate, and execute cleaning validation protocols, strategies, and documentation reports.
  • Facilitate technical discussions concerning cleaning methodologies, acceptance criteria, sampling approaches, and validation justifications.
  • Review and assess cleaning procedures, methods, and equipment sanitation practices.
  • Assist in risk evaluations related to product residue, cross-contamination risks, equipment design issues, and effectiveness of cleaning.
  • Set or review limits for acceptance, worst-case product selections, residue thresholds, and location of sampling points.
  • Collaborate closely with teams from Manufacturing, Quality Assurance, Validation, Engineering, and Quality Control.
  • Ensure that documentation complies with GMP, GDP guidelines, data integrity protocols, and site-specific quality standards.
  • Identify deficiencies in current cleaning validation procedures and propose practical enhancements.
  • Provide support for audit preparedness and respond to queries concerning cleaning validation during inspections or internal reviews.

Candidate Profile

  • Possess a bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a comparable field.
  • Demonstrate substantial experience in cleaning validation or qualification within pharmaceutical, biotechnology, or GMP-controlled manufacturing contexts.
  • Have in-depth knowledge of cleaning validation concepts, methodologies, and regulatory requirements.
  • Experienced in creating and reviewing cleaning validation protocols, reports, risk assessments, and related GMP documentation.
  • Understand GMP manufacturing equipment, cleaning processes, and sampling techniques like swab and rinse sampling.
  • Familiar with the cleaning validation lifecycle, revalidation tasks, and continuous process improvement initiatives.
  • Preferred exposure to health-based exposure limits, MACO, PDE/ADE calculations, and worst-case product selections.
  • Ability to work autonomously and supply technical expertise on cleaning validation topics.
  • Experience in supporting audits, inspections, remediation activities, or as a Validation Lead or Subject Matter Expert is advantageous.
  • Preferred familiarity with sterile manufacturing, biologics, vaccines, active pharmaceutical ingredients, or pharmaceutical production environments.
  • Exhibit strong leadership capabilities, communication, and stakeholder engagement skills.
  • Proficiency in English communication, both written and spoken.

Company Offerings

  • An international workplace embracing over 110 countries represented.
  • A culture founded on trust with leadership development opportunities; 70% of leaders started at entry-level roles.
  • Comprehensive training with internal academy and access to more than 250 training modules.
  • Dynamic workplace environment with regular events such as social gatherings and team-building activities.
  • Commitment to sustainability and social responsibility, empowering employees to lead projects with meaningful environmental and social impact through structured programs.

Equal Opportunity Statement

Our organization is dedicated to creating a diverse and inclusive environment, welcoming applicants of all genders, sexual orientations, races, ethnicities, beliefs, ages, marital statuses, disabilities, or other characteristics.

About the Employer

The company is a global, independent technology consultancy serving more than 1,000 clients worldwide with over 7,600 employees across 60+ countries. The business specializes in Information Systems & Digital, Telecom, Life Sciences, and Engineering sectors and fosters talent growth and professional development within a collaborative international community.

Recruitment Process

  • Initial brief virtual or phone interview to understand candidate motivations and fit.
  • Multiple in-depth interviews with the hiring manager and relevant team members covering experience, skills, job expectations, and company culture.
  • Possible technical assessments, role plays, or problem-solving exercises depending on the role.
  • Adaptable process tailored to individual candidates ensuring a positive recruitment experience throughout.

Minimum education

Bachelor's Degree

How they work

Communication Leadership Independence

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