The PKC (Process Knowledge & Control) expert, part of the PDTS (Process Development and Technical Services) organization, is responsible for executing Process Knowledge & Control activities in order to contribute to support manufacturing operations in their Life Cycle Management activities on manufacturing processes for phase III (Continued Process Verification - CPV) and commercial products.
He/She is in close contact with the Manufacturing/Quality organizations, with relevant process experts and with Global teams representatives. Key in this role is the development of robust monitoring plans that drive to becoming more pro-active.
About the position:
- Setup and maintenance of appropriate local monitoring system of process consistency indicators (PCIs) and critical quality attributes (CQAs) for process monitoring, according to Global indications
- Implementation and maintenance of monitoring plans
- Support and active participation in definition and implementation of Global initiatives concerning the PKC activities (Monitoring&Trending Harmonization, Process Knowledge System, Yields monitoring Harmonization)
- Support to Living documents systems and Product Quality Review concerning data analysis related to parameters included in monitoring plans
- Support for local implementation and improvement of software for monitoring (Discoverant)
- Mediation of Information Technology issues for Process Experts of Technical Services
- Support Technical Problem Solving Teams
- Compliance to cGMP?s, GDP?s, defining, implementing and maintaining appropriate SOP?s and training
Skills you need:
- 1 year experience in a pharmaceutical Environment. Preferable experience in area of process monitoring, process stabilitsation and optimisation.
- Experience of informatics and statistical tools
- Broad knowledge and experience within the GMP environment, Lean and SixSigma
- High level of customer orientation and organizational skills
- Knowledge of protein chemistry and especially the purification of plasma proteins
- Flexible in mind / out of the box thinker, inclination to team work
- Enthusiastic, motivating and convincing personality
- Good communication skills, verbal and written communication skills in German and English
- Preferable ability to lead multidisciplinary teams in the execution of a Project
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 3.065,25 gross per month (full-time); increased payment is possible. We are looking forward to your application.