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.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!