Validation Engineer - Pharma - English/French [F/M/X]

Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 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
Job Offer: Validation Project Coordinator

Mission Description:
As a Validation Project Coordinator, you will be responsible for leading and coordinating validation activities for major GMP projects related to Drug Substance and Drug Product manufacturing. You will ensure that validation strategies are state-of-the-art, from the planning phase through to the Validation Summary Report. Your responsibilities will include drafting, reviewing, and approving validation documents such as Risk Assessments, IQ/OQ/PQ protocols, and reports, as well as coordinating the execution of validation protocols.

Key Responsibilities:

• Coordinate validation activities for major GMP projects in Drug Substance and Drug Product.
• Develop and implement validation strategies and plans.
• Draft, review, and approve validation documentation (Risk Assessments, IQ/OQ/PQ protocols, reports).
• Oversee and coordinate the execution of validation protocols.
• Ensure compliance with regulatory requirements and internal standards.
• Collaborate cross-functionally within a matrix organization.

Profile Requirements:

• Minimum 5 years of experience in validation within a GMP environment.
• Expertise in IQ/OQ/PQ validation and strong knowledge of GMP.
• Experience in project management and working within a matrix organization.
• Excellent communication, organizational, and influencing skills.
• Experience with injectable product validation.
• Fluent in French and English.

• Commitment to Diversity:
  We are proud to be an equal opportunity employer. We are committed to promoting diversity within the workforce and creating an inclusive working environment. Therefore, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.