Qualification and Validation Engineer - Bern - 100%
Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.
For our international client based in Bern, Experis is currently looking for a Qualification and Validation Engineer for a contracting position of 5 months.
This position is for an hands-on Commissioning and Qualification Engineer responsible for the qualification and requalification process and QC equipment systems. The role will involve engaging with equipment vendors, manufacturing, quality, engineering & contractors.
- Start date: ASAP
- Duration: 5 months
- Work location: Bern
- Workload: 100%
Tasks & Responsibilities:
- Define the qualification strategy for production/ laboratory equipment, facilities, utilities and Computerized Systems (CSV).
- Perform the qualification of new or upgraded production / laboratory equipment, facilities, utilities and CSV through the preparation of the necessary documentation.
- Participate as SME to the URS preparation in support to the User for all defined steps.
- Perform the impact assessments, design, prepare the commissioning and qualification document and qualification reports.
- Collaborate in the upgrading documents and life cycle management of existing production / laboratory equipment, facilities and utilities according to a predefined frequency and in accordance with current SOPs.
- Ensure compliance of the qualification standards of the equipment/utilities through the continuous updating of procedures, according to international GMP standards and internal procedures.
- Maintain the qualification status of existing systems production / laboratory equipment, facilities, and utilities according to a predefined frequency and in accordance with current internal SOPs.
- Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning and qualification process are assessed and resolved.
You bring for this role the following qualifications:
- Engineer or experienced Bachelor with experience in the pharmaceutical/medical device or food sector, of at least 3-5 years
- Knowledge of current GMP standards and guidelines related to equipment, utilities and facilities qualification (e.g. ISO, ICH, FDA, ISPE)
- Knowledge of the necessary qualification and validation steps and tools (FMEA /HACCP RA, URS, DQ, IQ, OQ, PQ, SD&V, FPX)
- Knowledge of Good Engineering Practices
- Practical experience in the technical support of sterile production areas, as a plant engineer, internal project manager
- Detailed knowledge of GMP/HACCP requirements and their technical implementation in clean room classes A to D (EUGMP)
- Proactive, open personality that recognizes Production, Quality and R&D Departments as internal customers
- Team player with excellent communication skills
- English, good verbal and written (MANDATORY)
- German, fluent spoken and written (NICE TO HAVE)
- Integrated Microsoft applications (Windows Professional Office Package)
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt on +41 61 282 22 16.
Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.
Check out all of Experis' job openings at www.experis.ch or visit my personal page https://www.experis.ch/stephanie-vogt and connect to me on www.linkedin.com/in/stephanie-vogt2
+41 61 282 22 16