Senior Qualification Technician
We're looking for a Senior Qualification Technician in Leiden!
Do you have experience in a validation organization in biotechnology, pharmaceutical or process industry environment? Do you want to be responsible for the qualification of sterilization equipment, cleaning equipment, refrigerators, incubators, bioreactors for one of the biggest pharmaceutical companies of the world? Please get in touch to see if this could be your next job!
As a senior Qualification Technician you will be part of an engineering team which is responsible for engineering, project management and automation. The team looks after the correct qualification and validation status of GMP critical equipment and processes. You will be reporting to the supervisor of the validation group.
A Qualification Technician will lead, and coordinate, all (re-)qualification activities, as well organize life cycle (re-) qualification studies for e.g. sterilization equipment, cleaning equipment, refrigerators, incubators, bioreactors, etc. You will review and write/revise a variety of installation, operation and performance qualification related validation documents and provide input to the development of qualification/validation protocols, reports and other related system life cycle documents. Coordinate with the manufacturing areas, laboratories, Quality Assurance and other groups to plan, perform and report validation testing.
At this level the role has increased responsibility including, but not limited to, assisting in mentoring less experienced staff. This can also include secondary responsibilities e.g. Department Training Delegate function.
Last but not least you will be working with third parties to ensure safe and technical sound execution of the qualification activities in the field. Your main focus will be on quality and GMP related aspects of the Validation and qualification activities which will assure that support is delivered within the compliance regulations.
Your key responsibilities:
- Develop, revise and review qualification and validation protocols, reports, procedures and other sources of information to ensure that qualifications, validations and procedures are consistent with current industry, regulatory requirements, and current technology.
- Perform validation and qualification activities consistent with company validation policies and procedures and federal regulations.
- Coordinate with the manufacturing areas, laboratories and other groups to perform validation tests.
- Maintain the periodic review of validated systems schedules as specified.
- Recommend corrective actions on issues found and/or validation impact.
- Support risk assessment methodologies to assess commissioning, qualification and validation requirements.
- Support multidisciplinary project teams with validation expertise.
- Provides coaching and training and guidance on aspects of validations and qualifications.
- Acts as an expert for qualification and validation topics during both internal and external audits.
- Support internal and external Audits.
- Keep up to date with cGMP & validation guidelines.
- Validation support in the area of validation of cleaning, disinfection and sterilization processes.
- Bachelor or MBO+ in Technical or (Bio)Process Engineering oriented
- Experience in a validation organization preferably in biotechnology/pharmaceutical/process industry environment.
- Skills in communication, planning, documentation practices, risk analyses, working with validation life cycle documentation programs.
- Validation and qualification aspects of pharmaceutical and/or bio processing equipment (like bioreactors (or fermenters), Washing and sterilization systems (like autoclaves), cold storage equipment (like -80°C freezers).
- Basic understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and validation (e.g., FDA, GMP, ICH, etc.. ).
- Knowledge of (bio)process equipment and/or utility systems.
- Good technical writing and communication skills in English
- Quality critical mind set
- Problem solving oriented
- Strong team player
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