Cleaning Validation Specialist

Job Description

About the job

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

Your missions

• 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

Your profile

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or 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.

What We Offer

• 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.

Amaris Consulting is proud to be an equal-opportunity workplace. 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.

Who are we

Amaris Consulting 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.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!