Software Validation Engineer
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands.
You are a part of
The Reliability Solutions department of the company's Innovation Services is a diverse group of more than 80 technical experts. All have extensive experience in the field of Design for Quality and Reliability, Test and Verification engineering, and Regulatory. We are actively supporting complex, innovative projects for our customers from both internal the company's businesses, as well as, external companies, located all over the world.
• Act as a project manager and lead Computer System Validation (CSV) initiatives as assigned; perform activities to ensure CSV activities are performed, scheduled, planned, resourced and completed in accordance to established timelines.
• Work closely with other Q&R members, IT personnel, system business owners, end users, etc. to provide adequate support and expertise; communicate effectively and clearly throughout all levels of the organization.
• Guide stakeholders on software validation/quality relevance to establish suitable validation requirements and deliverables in accordance to FDA regulations and GAMP 5 principles.
• Assist in generating and maintaining a complete and accurate inventory of all validated systems, including comprising components, validation deliverables and relevant meta data and system ownership information ensuring the validated state of each system is readily known at all times.
• Perform and/or oversee CSV risk management activities; author/review risk assessments and perform risk mitigation activities as deemed appropriate.
• Ensure legacy systems are properly maintained and compliant based on current industry requirements and the company's s Policies.
• Measure and monitor CSV progress to senior management; generate reports and metrics as assigned.
• Work with records personnel to ensure all validation deliverables are accessible and easily retrievable if needed during an internal/external quality audit.
• Work with Document Control and Training Coordinators to assure concise CSV training materials are controlled, assigned, and maintained appropriately.
• Education: Bachelor's /Master's degree in Engineering.
• Demonstrated capability and experience in role.
• Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing. Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business. Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. Manufacturing software validation for medical devices within manufacturing environment. Guide and participate in bug testing, identification, and problem solving.
• The Software Validation Engineer role will work closely with the Software Validation Management Team, other Q&R personnel and various project teams throughout the organization and across multiple sites. Significant travelling is part of the job (approx. 50%). You will help provide regulatory guidance and perform project management duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards, and the company's Policies within the specific Business Group that we will assign to you.
• Bachelor’s degree and a minimum of 7 years of related CSV experience in the medical device or other FDA/ISO regulated industry
• Working knowledge of 21 CFR Part 11 and GAMP 5 is a required.
• Understanding of appropriate global medical device regulations, requirements and standards, including of the following is a plus: FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.
• Government/regulatory-body Quality System auditing/inspection experience (i.e., former FDA preferred)
• Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
• Attention to detail, organized and self-driven
• Solid interpersonal and communication skills
• Ability to communicate effectively both orally (English and German) and in writing (English); smart technical writing skills a must
• Effective time management; able to balance multiple projects simultaneously
• Open to other’s ideas and working collaboratively across functions and/or businesses throughout all levels of the organization
• Strong computer and technical writing skills.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim de Jong.
The Company
This client is an international pharmaceutical organization, specialized in the packaging and distribution of medicines with a powerful sense of shared purpose toward their mission: to serve patients.Role Description
In this role, you have the opportunity to ensure the high quality of the (medical) products that we create.You are a part of
The Reliability Solutions department of the company's Innovation Services is a diverse group of more than 80 technical experts. All have extensive experience in the field of Design for Quality and Reliability, Test and Verification engineering, and Regulatory. We are actively supporting complex, innovative projects for our customers from both internal the company's businesses, as well as, external companies, located all over the world.
Responsibilities
• Participate in all Computer System Validation (CSV) related project activities within scope, in support of achieving company objectives and the company's ongoing commitment to quality.• Act as a project manager and lead Computer System Validation (CSV) initiatives as assigned; perform activities to ensure CSV activities are performed, scheduled, planned, resourced and completed in accordance to established timelines.
• Work closely with other Q&R members, IT personnel, system business owners, end users, etc. to provide adequate support and expertise; communicate effectively and clearly throughout all levels of the organization.
• Guide stakeholders on software validation/quality relevance to establish suitable validation requirements and deliverables in accordance to FDA regulations and GAMP 5 principles.
• Assist in generating and maintaining a complete and accurate inventory of all validated systems, including comprising components, validation deliverables and relevant meta data and system ownership information ensuring the validated state of each system is readily known at all times.
• Perform and/or oversee CSV risk management activities; author/review risk assessments and perform risk mitigation activities as deemed appropriate.
• Ensure legacy systems are properly maintained and compliant based on current industry requirements and the company's s Policies.
• Measure and monitor CSV progress to senior management; generate reports and metrics as assigned.
• Work with records personnel to ensure all validation deliverables are accessible and easily retrievable if needed during an internal/external quality audit.
• Work with Document Control and Training Coordinators to assure concise CSV training materials are controlled, assigned, and maintained appropriately.
Requirements
• Experience: Minimum 8 years professional experience in the applicable role.• Education: Bachelor's /Master's degree in Engineering.
• Demonstrated capability and experience in role.
• Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing. Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business. Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. Manufacturing software validation for medical devices within manufacturing environment. Guide and participate in bug testing, identification, and problem solving.
• The Software Validation Engineer role will work closely with the Software Validation Management Team, other Q&R personnel and various project teams throughout the organization and across multiple sites. Significant travelling is part of the job (approx. 50%). You will help provide regulatory guidance and perform project management duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards, and the company's Policies within the specific Business Group that we will assign to you.
• Bachelor’s degree and a minimum of 7 years of related CSV experience in the medical device or other FDA/ISO regulated industry
• Working knowledge of 21 CFR Part 11 and GAMP 5 is a required.
• Understanding of appropriate global medical device regulations, requirements and standards, including of the following is a plus: FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.
• Government/regulatory-body Quality System auditing/inspection experience (i.e., former FDA preferred)
• Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
• Attention to detail, organized and self-driven
• Solid interpersonal and communication skills
• Ability to communicate effectively both orally (English and German) and in writing (English); smart technical writing skills a must
• Effective time management; able to balance multiple projects simultaneously
• Open to other’s ideas and working collaboratively across functions and/or businesses throughout all levels of the organization
• Strong computer and technical writing skills.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim de Jong.
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