COMMISSIONING & QUALIFICATION LEAD

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 44 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Following a new opportunity, we are currently looking for a Commissioning & Qualification Lead in Zaragoza (Spain).Fundamental requirements:5+ years' experience in the biotechnology/pharmaceutical industries with a minimum of 3 years relevant experience performing C&Q activities within GMP environmentKnowledge of the typical execution flow of pharmaceutical equipment validation and standard reference protocolsEnglish and Spanish language fluency in speaking and writing (at least B2)First Project you will be assigned to:Location: Zaragoza, Spain100% onsiteDuration: at least 2 years (We offer a permanent contract with a relocation package if the resourse it's not resident in Spain).You will be responsible for:Preparation and execution of the main validation activities of Pharma products, both in the company and at the customerCommissioning & Qualification for Facility, Process, HVAC, Clean Room and Utility Services (monitoring FAT, SAT e DQ activities), Risk Assessment / Design Qualification / Validation Plan draftingDrafting, verification and execution of protocols and qualification test (FAT, SAT, IQ, OQ, PQ) and thermal validation study protocolsGuaranteeing the training of the internal technical staff and the staff of the distributors on the standard procedures to be performed during the validation of the products, in the company and at the customer, in compliance with the reference regulations and company policies.Managing the preparation and execution of the validation of Phama services by verifying the correctness of the protocols issued by the Technical Office in compliance with the contractual requirements of customers, maintenance and assists the customer on site.Handling the closure of the open points and/or any critical situations emerged at the customers during validation, and the pre fat and fat phase on the machines/systems destined to PharmaNext StepsUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.