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Validation Engineer
Eingestellt von Elevate Direct
Gesuchte Skills: Engineer, Engineering
Projektbeschreibung
Validation Engineer - Normal - Beerse
The Janssen Clinical Pharmacology Unit (CPU) is the competency center preferred by R&D Operations and the Therapeutic Area business partners for the conduct of safe, efficient and effective first-in- human and complex exploratory clinical studies.
The Validation Engineer will assist the local Validation Lead to guarantee that all computerized systems, equipment and processes at the CPU are adequately validated and qualified in compliance with the required regulations and guidelines.
Roles and Responsibilities
The Validation Engineer reports to the Validation Lead at the CPU
Under supervision of the Validation Lead the Validation Engineer is responsible for
o Directing the validation activities in close collaboration with the CPU business partners, Q-CSV and BU IT manager
o Qualification and validation execution according to the System Development Life Cycle procedures and methodologies
o Preparing the required compliance plans and reports
o Preparing the user acceptance test protocol
o Preparing the user acceptance test scripts
o Coordinating the user acceptance testing with the CPU business partners, Q-CSV and BU IT manager
o Analysing and documenting the user acceptance test results
o Resolving user acceptance test problems
o Contributing to the development and maintenance of specific work instructions and SOPs
Technical Requirements
Broad experience in Computer System Validation (CSV) and testing
o Acquainted with 21 CFR Part 11, GxP and ICH regulations
Excellent technical writing skills
Extensive knowledge of the System Development Life Cycle (SDLC) methodology, experience with the Janssen SDLC methodology and corresponding templates is a plus
o Acquainted with both the agile and waterfall software development methodology
o Solid understanding of the fundamentals of iterative and incremental software development
Good project management skills
Familiar with clinical trials processes in the Pharmaceutical industry
Soft Skills
Excellent interpersonal and communication skills
Quick learner and motivated self-starter
Strong analytical and problem-solving skills
Team focused and excellent collaboration skills across functions
Strong tracking, coordination and project management skills
Effective decision-making skills and judgement
Ability to identify and implement process and/or application improvements
Ability to work on multiple simultaneous tasks with limited supervision
Ability to follow change management procedures and internal guidelines
Sense of urgency
Some flexibility in working hours is required
Methodology and Certification Requirements
Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or
Bioinformatics OR equivalent through experience
Advanced course work in technical systems plus continued education in technical disciplines is preferred
Additional certification in Computer System Validation is a plus
Language Proficiencies
Dutch: spoken and written
English: spoken and written
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
The Janssen Clinical Pharmacology Unit (CPU) is the competency center preferred by R&D Operations and the Therapeutic Area business partners for the conduct of safe, efficient and effective first-in- human and complex exploratory clinical studies.
The Validation Engineer will assist the local Validation Lead to guarantee that all computerized systems, equipment and processes at the CPU are adequately validated and qualified in compliance with the required regulations and guidelines.
Roles and Responsibilities
The Validation Engineer reports to the Validation Lead at the CPU
Under supervision of the Validation Lead the Validation Engineer is responsible for
o Directing the validation activities in close collaboration with the CPU business partners, Q-CSV and BU IT manager
o Qualification and validation execution according to the System Development Life Cycle procedures and methodologies
o Preparing the required compliance plans and reports
o Preparing the user acceptance test protocol
o Preparing the user acceptance test scripts
o Coordinating the user acceptance testing with the CPU business partners, Q-CSV and BU IT manager
o Analysing and documenting the user acceptance test results
o Resolving user acceptance test problems
o Contributing to the development and maintenance of specific work instructions and SOPs
Technical Requirements
Broad experience in Computer System Validation (CSV) and testing
o Acquainted with 21 CFR Part 11, GxP and ICH regulations
Excellent technical writing skills
Extensive knowledge of the System Development Life Cycle (SDLC) methodology, experience with the Janssen SDLC methodology and corresponding templates is a plus
o Acquainted with both the agile and waterfall software development methodology
o Solid understanding of the fundamentals of iterative and incremental software development
Good project management skills
Familiar with clinical trials processes in the Pharmaceutical industry
Soft Skills
Excellent interpersonal and communication skills
Quick learner and motivated self-starter
Strong analytical and problem-solving skills
Team focused and excellent collaboration skills across functions
Strong tracking, coordination and project management skills
Effective decision-making skills and judgement
Ability to identify and implement process and/or application improvements
Ability to work on multiple simultaneous tasks with limited supervision
Ability to follow change management procedures and internal guidelines
Sense of urgency
Some flexibility in working hours is required
Methodology and Certification Requirements
Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or
Bioinformatics OR equivalent through experience
Advanced course work in technical systems plus continued education in technical disciplines is preferred
Additional certification in Computer System Validation is a plus
Language Proficiencies
Dutch: spoken and written
English: spoken and written
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik