Cleaning Validation RDP Writer

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!

Job description

We are seeking a skilled and detail-oriented Cleaning Validation RDP (Report/Data Package) Writer to support the final documentation phase of cleaning validation projects on-site in North York, within a GMP-regulated pharmaceutical or biotechnology setting. This role is critical to ensure that all executed cleaning validation protocols are accurately and thoroughly documented, in full compliance with internal procedures and global regulatory requirements. If you have a strong background in technical writing, data analysis, and GMP documentation—and thrive under deadline-driven conditions—this is an excellent opportunity to contribute to high-impact validation work.

Key Responsibilities

• Compile and analyze raw data from executed cleaning validation protocols, including swab and rinse results.
• Interpret and explain any deviations or anomalies observed during validation execution.
• Author detailed Cleaning Validation Reports (RDPs), ensuring clarity, accuracy, and compliance with GMP documentation standards.
• Collaborate closely with validation engineers, QA teams, and laboratory personnel to resolve data discrepancies.
• Ensure timely completion and submission of all validation documentation to meet production and compliance deadlines.
• Maintain strict adherence to GDP (Good Documentation Practices) and internal SOPs.
• Manage multiple documentation projects simultaneously, prioritizing tasks based on urgency and regulatory timelines.
• Support audit readiness by ensuring that documentation is accurate, complete, and properly archived.

Requirements

• Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or a related technical discipline.
• 4-6 years of experience in validation documentation, technical writing, or QA/Compliance roles within a GMP-regulated environment.
• Prior experience with Sanofi and familiarity with their documentation processes is a strong asset.
• Solid understanding of cleaning validation principles, swab/rinse sampling, and regulatory expectations (FDA, EMA, etc.).
• Proficiency in Microsoft Office Suite, especially Word and Excel, for data analysis and report generation.
• Excellent written communication skills with a strong command of English technical writing.
• High level of attention to detail, analytical thinking, and accountability.
• Ability to work independently with minimal supervision.
• Flexibility to work evening shifts and weekends in alignment with production timelines and documentation deadlines.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.