GMP Consultant - Cleaning and Sterilization Validation, as well as Single-Use Technology (m/f/d)

As a GMP consultant, you are involved in the planning, implementation and documentation of qualification and validation activities for pharmaceutical plants, systems and processes. The focus is on regulatoryly loadable and documentable evidence of the specific function of plants and processes as well as the effectiveness and reproducibility of cleaning and sterilization processes. Their tasks include in particular: management and implementation and development and implementation of qualification and validation projects and strategies for pharmaceutical and biotechnological production plants; development and implementation of qualification and validation strategies focusing on single-use technology; planning, carrying out and evaluating risk analyses and deriving appropriate training and validation measures; preparation and professional processing of qualification and validation plans, test protocols, reports and procedural instructions; planning and monitoring of measurements and tests in the field of temperature and sterilization validation as well as technical assistance to our measuring and testing equipment and laboratory partners; ensuring compliance with relevant GMP requirements and other relevant regulatory requirements; Technical consulting of our customers and coordination of qualification and validation activities within our specialist and general planning projects. The special: You do not work in isolation on individual documents, but are integrated into the projects from the conception through technical implementation to successful qualification and validation.

You are delighted to solve complex technical issues, take responsibility and develop resilient solutions together with customers and project teams. Ideally you bring: a completed study (Master/Diplom) of pharmaceutical engineering, chemical engineering, biotechnology or a comparable subject; multiannual professional experience in the qualification and validation of pharmaceutical production facilities and processes; practical experience with qualification and validation methods such as IQ, OQ and PQ and ideally with cleaning or process validation; practical experience in handling measuring and testing equipment, in particular in the environment of temperature and sterilization validation; secure knowledge of relevant GMP requirements and relevant European and international regulatory requirements; a strong technical understanding, a structured and independent way of working as well as the joy of customer contact and project responsibility; very good knowledge of German and English, willingness to project-related travel as well as a driving licence of class B.

At Process [.-ING] you will not only expect exciting projects, but also an environment in which you can actively shape your professional and personal development: Responsibility and design space You take independent responsibility in demanding pharmaceutical and biotech projects and actively shape technical solutions. Technical development We offer you attractive professional and personal training and development opportunities – with a perspective on a function as a leading GMP consultant. Demanding projects Different customers, technologies and project phases ensure the professional width and new challenges instead of daily routine. Security and perspective You work in an established, owner-managed engineering and consulting company with a long-term perspective. Flexibility Flexible working hours and the possibility of hybrid work support a project-oriented design of everyday work. Attractive remuneration We offer a fair remuneration and participation in our bonus program. Health and coexistence A collegial working environment with short decision-making paths as well as our operational health management including Wellpass complete our offer. Why Process [.-ING]? At Process [.-ING], around 300 employees work to develop and implement technical solutions for the pharmaceutical and biotechnology industry. You meet our technical depth, practical engineering work and demanding project responsibility – combined with the development possibilities and short decision-making paths of an owner-managed company. If you want to introduce your experience and take the next step in your professional development, we look forward to meeting you. Design the pharmaceutical factory of the future with us. .