GMP Consultant - Fill & Finish (m/f/d)

As a GMP Consultant (m/w/d) Fill & Finish, you are involved in the planning, implementation and documentation of qualification and validation activities for pharmaceutical production plants and processes. The focus is on regulatoryly loadable and comprehensible evidence of the specific function of plants and processes and their reproducible performance. Their tasks include in particular: management and implementation and development and implementation of qualification and validation projects and strategies for pharmaceutical plants; accompanying the qualification and validation of production and filling systems and associated systems and processes; planning, carrying out and evaluating risk analyses and deriving appropriate training and validation measures; Creation and professional processing of qualification and validation plans, test logs, reports and method instructions planning, coordination and evaluation of qualification and validation activities within interdisciplinary project teams; Ensuring compliance with relevant GMP requirements and other relevant regulatory requirements Identification of optimization potentials and support in the development of resilient technical solutions 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 master's degree in pharmaceutical engineering, chemical engineering, biotechnology or a comparable technical or scientific field; multiannual professional experience in the qualification and validation of pharmaceutical production plants and processes ideally practical experience in the field of filler & finish, aseptic production or pharmaceutical filling processes; practical experience in process optimization with a training on Black-Belt level. practical experience with training and validation methods such as IQ, OQ and PQ as well as in the planning and evaluation of risk analyses; 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]? Fill & Finish is one of the crucial interfaces between pharmaceutical production, technology and quality. Right here you can contribute to your experience and help modern production processes be implemented safely, reproducible and GMP-compliant. At Process [.-ING] you will meet the 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. .