C&Q Engineer

  • Salary: 85-105 CHF per hour (all incl)
  • REF Number: 00051216
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 23.07.2021
  • Closed Date: 14.10.2021
  • Sector:
  • Location: Bern, Bern Area
  • Discipline: Technical - Validation, Technical - Maintenance Engineer

CK QLS are recruiting for a C&Q Engineer to join an important project with a global Pharmaceutical Company at their site based in Bern on a contract basis until the end of the year.

C&Q Engineer Role: The main purpose of the role will be to:

  • Ensure that Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
  • Ensure that Qualification/Validation Master plansare up to date and established for all ongoing projects in QC.
  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation).
  • Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaborationwith internal and external partners.
  • Coordination and oversight of external suppliers.
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics.
  • You will be especially dedicated to activities related to thermal mapping and autoclave.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Bachelor/Master degree in Technical or Natural Sciences.
  • A minimum of 3 years of working experience within pharma company in C&Q equivalent position.
  • Know-how of commissioning and qualification requirements according to (c)GMP regulations.
  • Know-how of quality assurance principles and experience working with cross-department stakeholders.
  • Excellent communication skills.
  • Analytical thinking and problem-solving ability.
  • Business fluency in English.
  • German language is a plus.
  • Self time management.

Apply: For more information or to applyfor this C&Q Engineer position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch, quoting job ref 51216.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.