Due to a constant growth, PQE is looking for a MES Validation Consultant to join our DACH Team. In this full-time role, the Consultant will be part of the MES Project Team and will participate in projects in the DACH area, such as define the local testing strategy (IQ, OQ, MBR Verification and PQ/UAT), write and review validation test scripts, be responsible for the delivery of the local MES validation package (Validation Plan, Risk Assessment, Test Plan, Trace Matrix, and Test Scripts). The Consultant will work alone or more frequently as part of multidisciplinary teams (either as leader or team member), depending on the nature and complexity of the project.
Main Area of Expertise:
- experience in validation of manufacturing or automation software
- Knowledge & experience on MES system
- Knowledge and experience in Pharmaceutical Manufacturing processes like Weighing & Dispensing
- Knowledge of validation and regulation requirements including GAMP, 21 CFR part 11 and GMP
- Experience in Computerized System Validation and knowledge of System Development Life Cycle
- Experience with testing tools such as HP ALM
Skills:
- Leadership
- Team work
- Relational & communication skills
- Project management
- Resource management
- Proven analytical and problem solving skills
- Prioritization skills
- strong analytical skills and attention to details
- availability to travel (up to 50%)
Education:
Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
Location:
Germany, Austria, Switzerland - Subsidiary: Holzkirchen (Bavaria)/Homeoffice
Languages:
Fluent GERMAN (at least B2/C1 Level)
Fluent English (at least B2/C1 Level)
Why PQE:
PQE Group is a leading quality solution provider for the Life Science industry, in both high level and hands on consulting services around the world. With 26 offices and a global presence, the PQE Group supports small, medium and large sized organizations in their development and compliance-related challenges with specific capabilities in: Data Integrity Assurance, Digital Governance, Qualification & Engineering, Laboratory Excellence, Quality Compliance, Regulatory Affairs and Audits.
PQE Deutschland GmbH
Bergfeldstr. 1 –83607
Holzkirchen Germany
Geschäftsführer: Markus Sappl
HR Munchen: HRB220105
Steuernummer: 11413530352
USt.-IdNr. DE301201404
Hypovereinsbank Erding
IBAN:
DE23 70020270 0015525450
BIC: HYVEDEMMXXX
Tel. +43 664 1212 601
www.pqegroup.com
