Overview To reinforce the OTS (Outsourced Technical Services) team PM Group is searching for a SENIOR VALIDATION ENGINEER to support an important project on site at a client in the region of Brussels. This role is open for employees or freelancers. PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors. Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients. To do this our people are key and is where you can play a part. Responsibilities Responsibilities As Senior Validation Engineer/ PQ Specialist, and as part of an integrated project team, you drive the PQ preparation and execution activities of the project ensuring they are completed in accordance with system requirements, specifications, quality attributes and project procedures/ guidelines. Scope: Clean Utilities (water, gas, air, steam, decontamination station) Facility Environmental Monitoring (classified area PQ) Temperature control units (fridge, freezer, incubator, thawing cabinets, coldrooms, ambient areas) Cleaning (Parts Washer cleaning cycle, CHT and DHT) Sterilisation (Autoclave sterilisation cycle, SHT) Vial Filling (Filling accuracy under grande A) Decontamination (VHP isolator, H2O2 classified areas) Automation (CSV) Media Simulation/ Media Fill (APS) Process Confirmation Run (Clinical Manufacturing): Water batch, Mock-up, Engineering runs. Qualifications Qualifications & Requirements Bachelor or Master level is required Deep understanding and experience of all PQ verification strategy and testing Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution Extensive knowledge and experience with Process Performance testing: Mock-up, Media Simulation, Media Fill, Engineering runs is preferred. Expert in all Biotech process, in DS/DP and ideally in Gene therapy rAAV Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for single use for Pharmaceutical / Biotechnology projects including automation related aspects of equipment is preferred Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. Expert in reviewing and writing technical reports Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions) Fundamental understanding of standard pharmaceutical analytical testing Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred Knowledge of safety, GMP and environmental regulatory requirements Ability to make decision under pressure and demonstrated strong communication/ leadership skills, great interpersonal and initiative skills Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes English speaking is a must, knowledge of French and Dutch is a plus