Sartorius is a leading international partner of biopharmaceutical research and the industry. In fiscal 2019, the company earned sales revenue of some 1.83 billion euros.
At the end of 2019, more than 9,000 people were employed at the Group’s approximately 60 manufacturing and sales sites, serving customers around the globe. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise, while thriving in a vibrant and innovative environment. Consultant (m|f|d) Process Qualification We are currently seeking a Consultant (m|f|d) Process Qualification based at our site in Guxhagen, Germany (Sartorius Stedim Systems).
In this position, you will provide commissioning and qualification services to Sartorius customer in project business. Additionally you will support front end studies to fulfill customer needs in the early sales phase. Therefor you check design documents in relation to GDP|GMP standards and technical reliability.
Your main responsibility is the development of C&Q (commissioning & qualification) planning and documents for various projects With respect to GDP conditions you generate and execute C&Q protocols for example RTM, RA, design qualification You hold the responsibility for maintaining requirement traceability matrix for C&Q requirements You read and verify equipment drawings like P&ID or AF&ID´s and design documents You develop Standard Operating Procedures (SOPs), process workflows, Turnover Packages, and other regulatory support documentation Your customer centric approach require to build stronger relationships, to consult them and provide right solutions You support internal stakeholders like sales and project management with technical and quality related knowledge You will support globally for above mentioned activity to integrate the business processes and training for required Q activities You have finished your bachelors degree in bioprocess engineering, industrial or process engineering or a comparable qualification Additionally you have several years of relevant professional experience in a job related position In handling of norms and condition like GMP|GDP, US FDA and EU EMEA ICH guidelines Good knowledge of ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Also you have knowledges in ISPE Baseline Guide 5 Commissioning and Qualification, ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems and other ISPE C&Q relevant guidelines Ability to negotiate with other project team members to achieve project goals Fluency in English and willingness to travel to various client locations globally Identification with our core values: Sustainability, Openness, Enjoyment Sartorius’ ambition is to simplify progress in the bio- pharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. Nearly 10,000 employees at more than 60 sites are working together on achieving our goal: Better health for more people. And together, we have grown strongly over the past years.
Enjoy the advantages of working with a global player: Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration Work-life balance: Working from home at many sites Intelligent working environment: working in smart buildings with the latest technology and equipment Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow its global team to approximately 15,000 people in 2025.
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