PQE Group is seeking a C&Q Consultant to support commissioning and qualification activities. The candidate will work closely with engineering, QA, validation, and construction teams to ensure that systems and equipment meet regulatory and operational standards prior to handover.
Responsibilities
Perform and support DQ, IQ/IV, OQ/OV, and PQ activities in line with GMP requirements
Support FAT and SAT activities, including coordination with vendors and contractors
Execute field verification, system walkdowns, and observation listing, and track resolution of deviations
Conduct verification execution for utilities, equipment, and cleanroom systems
Perform vendor package assessments and ensure completeness and compliance
Review and manage turnover packages to ensure readiness for qualification
Coordinate closely with design, construction, and QA teams to ensure timely system readiness
Participate in risk assessments and ensure alignment with the project validation strategy team
Ensure all activities are documented in accordance with Good Documentation Practices (GDP)
Required Qualifications
Minimum 7 years of experience in C&Q or validation roles, preferably in the pharmaceutical or biotech industry
Solid knowledge of GMP regulations, commissioning processes, and qualification protocols
Ability to interpret P&IDs, technical drawings, URS, FAT, and SAT documentation
Experience with clean utilities, HVAC, process equipment, or automation systems is a plus
Strong organizational skills, attention to detail, and ability to work in a fast‑paced project environment
Excellent communication and documentation skills, with a strong team-oriented mindset
Fluent in German and English
Demonstrated site‑specific discipline expertise
Benefits & Culture As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
#J-18808-Ljbffr
Responsibilities
Perform and support DQ, IQ/IV, OQ/OV, and PQ activities in line with GMP requirements
Support FAT and SAT activities, including coordination with vendors and contractors
Execute field verification, system walkdowns, and observation listing, and track resolution of deviations
Conduct verification execution for utilities, equipment, and cleanroom systems
Perform vendor package assessments and ensure completeness and compliance
Review and manage turnover packages to ensure readiness for qualification
Coordinate closely with design, construction, and QA teams to ensure timely system readiness
Participate in risk assessments and ensure alignment with the project validation strategy team
Ensure all activities are documented in accordance with Good Documentation Practices (GDP)
Required Qualifications
Minimum 7 years of experience in C&Q or validation roles, preferably in the pharmaceutical or biotech industry
Solid knowledge of GMP regulations, commissioning processes, and qualification protocols
Ability to interpret P&IDs, technical drawings, URS, FAT, and SAT documentation
Experience with clean utilities, HVAC, process equipment, or automation systems is a plus
Strong organizational skills, attention to detail, and ability to work in a fast‑paced project environment
Excellent communication and documentation skills, with a strong team-oriented mindset
Fluent in German and English
Demonstrated site‑specific discipline expertise
Benefits & Culture As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
#J-18808-Ljbffr
Senior C&Q Consultant (Pharma / Life Sciences) Arbeitgeber: PQE Group
Die PQE Group ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in der Pharma- und Medizintechnikbranche nicht nur ein dynamisches Arbeitsumfeld bietet, sondern auch zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung. Mit einem engagierten Team in Bern, Schweiz, fördern wir eine Kultur der Zusammenarbeit und des Wissensaustauschs, während wir gleichzeitig die höchsten Standards in der Dokumentation und Qualitätssicherung einhalten. Unsere Mitarbeiter profitieren von einer stabilen Unternehmensstruktur und der Chance, an langfristigen Projekten mitzuarbeiten, die einen echten Unterschied in der Branche machen.
