Process Validation Consultant

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 Systems & 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 youThe objective?Learn about you, understand your motivations, and make sure we have the right job for youInterviews(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 opportunitiesCase 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 youJob descriptionJoin our team asProcess Validation Consultantand start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field but above all being an ambassador of our organization to clients thanks to:Your interpersonal skills and ability to listen in order to build a strong relationship of trust with our clients and fully understand their challenges and issues.Your curiosity and eagerness to learn as we support over **** clients from all sectors worldwide.Your missionsConduct risk assessment activities for sterile production processes.Support external suppliers in gathering information for drafting risk assessments.Review Commissioning, IQ (Installation Qualification), and OQ (Operational Qualification) protocols.Support threshold study activities related to visual inspection.Ensure equipment qualification aligns with CGMP standards.Supervise and provide guidance for sterile production process validation.Provide CGMP training to staff, ensuring regulatory compliance.Prepare updates for MS&T activities and share project progress during weekly meetings.Your profileExperience with CGMP and sterile production environments.Experience with qualification protocols: Commissioning, IQ, and OQ.Experience with process validation and threshold studies.Experience with risk assessment in pharmaceutical manufacturing.Academic background: degree in Life Sciences, Engineering, or related fields.Fluent Italian and English.You have strong analytical skills, attention to detail, and the ability to work effectively in a team environment.What we offerAn international community bringing together 110+ different nationalitiesAn environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilitiesA robust training system with our internal Academy and 250+ available modulesA vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)Strong commitments to CSR notably through participation in our WeCare Together programRemote policy: On-site project – no remote option available for this positionAmaris 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.#J-*****-Ljbffr