Job Summary
CSV and Quality Lead
Purpose of the position Global Animal Health Manufacturing IT Boxmeer delivers IT and automation solutions to the manufacturing sites Boxmeer and De Bilt. This encompasses a wide range of manufacturing technology, including PLCs, SCADAs, historians, MES systems and supporting IT applications, all aligned to a goal of ensuring frictionless flow of data and more efficient business operations.
You will have the opportunity to develop and drive the consistent delivery of CSV and Quality services across the various projects teams. Besides contributing CSV and Quality services to projects, you will also be responsible for developing the CSV competence and will provide oversight and guidance to the CSV analysts in the area teams. You will work closely with the Business Technology Partners to ensure the right level of quality and CSV services are delivered according to the MSD AH Quality Management System. You will report to the Site Digital Technology Lead, with a dotted line to the GAHM IT global CSV and quality lead.
Primary activities
· Drive standardization of and adherence to CSV methodologies and procedures across project teams based on global standards.
· Lead the validation planning and design efforts and provide oversight to the CSV analysts.
· Support quality oversight of change control and validation activities as related to regulated computer systems for 21 CFR Part 11 compliance.
· Ensure and promote collaboration with other IT divisions as well as parts of our manufacturing network, both locally and globally, to break-down organizational boundaries in favour of a highly collaborative and customer-centric culture.
Your profile
· Bachelor’s degree with relevant experience in Computer Science, Computer Science Engineering or equivalent experience.
· At least 5 years’ experience in a highly regulated manufacturing environment, such as pharma, biotechnology, food or chemicals.
· At least 3 years proven CSV experience.
· Understanding of GxP regulated environment and validation requirements.
· Certified in xxx methodologies.
· Preferred experienced in working with digital tools to support validation
· Effective interpersonal and communication skills, both verbal and written in English and preferable in Dutch.
· Currently living near the site in Boxmeer, Netherlands. Relocation support is not offered.
Key Responsibilities
CSV and Quality Lead
Purpose of the position Global Animal Health Manufacturing IT Boxmeer delivers IT and automation solutions to the manufacturing sites Boxmeer and De Bilt. This encompasses a wide range of manufacturing technology, including PLCs, SCADAs, historians, MES systems and supporting IT applications, all aligned to a goal of ensuring frictionless flow of data and more efficient business operations.
You will have the opportunity to develop and drive the consistent delivery of CSV and Quality services across the various projects teams. Besides contributing CSV and Quality services to projects, you will also be responsible for developing the CSV competence and will provide oversight and guidance to the CSV analysts in the area teams. You will work closely with the Business Technology Partners to ensure the right level of quality and CSV services are delivered according to the MSD AH Quality Management System. You will report to the Site Digital Technology Lead, with a dotted line to the GAHM IT global CSV and quality lead.
Primary activities
· Drive standardization of and adherence to CSV methodologies and procedures across project teams based on global standards.
· Lead the validation planning and design efforts and provide oversight to the CSV analysts.
· Support quality oversight of change control and validation activities as related to regulated computer systems for 21 CFR Part 11 compliance.
· Ensure and promote collaboration with other IT divisions as well as parts of our manufacturing network, both locally and globally, to break-down organizational boundaries in favour of a highly collaborative and customer-centric culture.
Your profile
· Bachelor’s degree with relevant experience in Computer Science, Computer Science Engineering or equivalent experience.
· At least 5 years’ experience in a highly regulated manufacturing environment, such as pharma, biotechnology, food or chemicals.
· At least 3 years proven CSV experience.
· Understanding of GxP regulated environment and validation requirements.
· Certified in xxx methodologies.
· Preferred experienced in working with digital tools to support validation
· Effective interpersonal and communication skills, both verbal and written in English and preferable in Dutch.
· Currently living near the site in Boxmeer, Netherlands. Relocation support is not offered.