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Senior Qualification Technician
Requisition ID: 1700208066W
Janssen IDV is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Within Janssen IDV talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen IDV.
Janssen IDV is part of Johnson & Johnson.
For our Engineering Validation & Maintenance (EVM) department we are currently seeking for a fulltime;
Senior Qualification Technician (m/f)
The EVM department is responsible for the total technical support of all facilities, utilities, production and laboratory areas and involved equipment. The main EVM activities are executed by three groups; Engineering takes care of projects that impact the existing situation. The Validation group looks after correct qualification and validation of GMP critical equipment and processes. The maintenance group is responsible for timely maintenance and calibration of all the utilities and equipment throughout all the 4 facilities on the Janssen IDV Leiden site.
As a senior Qualification Technician you will be reporting to the supervisor of the EVM validation group.
You will lead, and coordinate, all (re-)qualification activities under EVM’s responsibility, 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 role can also include secondary responsibilities e.g. Department Training Delegate function for the EVM department.
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 of the Pharmaceutical and Johnson & Johnson standards and guidelines.
- 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 a Subject Matter Expert (SME) for qualification and validation topics during both internal and external audits.
- Support internal and external Audits.
- Keep up to date with cGMP & validation guidelines like EMEA and FDA.
- Validation support in the area of validation of cleaning, disinfection and sterilization processes.
Education: 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.
- For bachelor level minimum of 2- 4 years work experience or for MBO+ more than 4 years of experience in similar field of expertise.
- Working in a biotechnology/pharmaceutical environment.
- Good technical writing and communication skills in English
- Quality critical mind set
- Problem solving oriented
- ‘Can do’ mentality
- Strong team player
Janssen Vaccines & Prevention BV (8852)