Are you interested in working as part of the Commissioning & Qualification (C&Q) team?
You will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies in the areas of manufacturing equipment, upstream or downstream biopharmaceutical manufacturing equipment and processes, performing the C&Q activities listed below?
We are looking for a Commission and Qualification support engineer, this person will be ensure that the facilities, systems and equipment are designed and installed as specified and function correctly also since there is a qualification component you will also be product-focused and can be divided into three separate streams: Installation qualification (to ensure equipment is installed correctly), operational qualification (to check that equipment operates as it's intended to), and performance qualification (that the equipment performs as it needs to over a period of time). It ensures equipment and systems function to produce products correctly.
- Layout development and review for material and personnel flow compliance Commissioning and qualification protocol
- Risk assessments and FMEA assessments for process and equipment, HAZOP
- Develop system impact assessments, validation plans, protocols and reports that support the
- Qualification and validation of systems.
- Commissioning and validation of manufacturing equipment, downstream equipment and processes
- Review analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
- Investigate deviations, write investigation reports and create summary reports.
- Promote cGMP and regulatory compliance into assigned projects.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- +7 years of experience in the pharma industry
- Experience in commissioning and qualification
- Experience working with DSP/USP, Small Equipment, Autoclave
- Biopharma/Pharma experience
- Knowledge in process equipment
- technical aspects but also redaction of protocols,
- knowledge of GMP
- fluent in French and English
- writing protocol
- A balanced salary package based on your capabilities and experience
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 16951