(Senior) Regulatory Validation Coordinator

Location

Zwijnaarde

Working hours

Full-time

Contract Type

Permanent

Working area

Licence to Operate (LTO)

Join the team

We are BASF in agriculture and everything we do, we do for the love of farming. Connecting seeds and traits, crop protection products, digital tools and sustainability approaches, to help deliver the best possible outcomes for farmers, growers and our other stakeholders along the value chain. We do everything in our power to build a sustainable future for agriculture by connecting innovation, customers and society.

Responsibilities

You will execute assigned validation and verification activities for new laboratory and computerized systems and changes to existing systems, in accordance with the approved validation strategy, agreed priorities and applicable OECD GLP requirements.
You will prepare and maintain computerized system lifecycle documents and applicable SOPs, ensure they remain accurate, traceable and current, and coordinate review and approval by the designated owner.
You will perform validation impact and risk assessments, recommend proportionate controls and escalate decisions beyond the defined framework.
You will coordinate deviation investigations, root-cause analysis and CAPA follow-up and escalate significant risks, overdue actions or decisions requiring management approval.
You will coordinate and ensure the timely completion of calibration activities for assigned laboratory equipment, in accordance with approved procedures, schedules and priorities.
You will apply specialist expertise in GLP validation, computerized system compliance and data integrity and provide practical guidance to stakeholders.
You will provide first-line operational IT support for assigned laboratory systems, coordinate issue resolution and escalate matters requiring system-owner or IT decisions.
You will prepare assigned validation and calibration areas and documentation for GLP audits and regulatory inspections and coordinate follow-up actions allocated to the role.
You will identify improvement opportunities, recommend practical enhancements and coordinate approved changes within the assigned scope.
You will coordinate assigned activities across laboratory operations, Quality Assurance, IT, system owners and suppliers, track progress and escalate delivery risks.

Qualifications

You have a bachelor’s or master’s degree in Life Sciences, Biotechnology, Chemistry, Engineering, IT or a related field.
You have relevant professional experience in GxP validation or another regulated environment and can independently coordinate defined validation, documentation or quality-related activities.
You have knowledge of GAMP 5 and applicable OECD GLP guidelines.
You have knowledge of FDA 21 CFR Part 11 requirements, which is considered an advantage.
You are accurate, service-minded and collaborative, with a positive and hands-on attitude.
You have strong organizational and planning skills and can manage multiple priorities.
You show a strong interest in laboratory systems, computing technologies and data management.
You have excellent oral and written communication skills and are fluent in English.

Benefits

You will join a committed and collaborative team in an international, regulated environment. From day one, you will take on meaningful responsibilities and receive structured on-the-job training and knowledge transfer to further develop your expertise in GLP validation, computerized systems, data integrity and laboratory equipment calibration.

We offer competitive compensation and attractive benefits, together with opportunities for professional development and career growth within an international company.

Come join us in bringing the lab to the field

About BASF’s Agricultural Solutions division

Everything we do, we do for the love of farming. Farming is fundamental to provide enough healthy and affordable food for a rapidly growing population, while reducing environmental impacts. That’s why we are working with partners and experts to integrate sustainability criteria into all business decisions. We invest in a strong R&D pipeline, combining innovative thinking with practical action in the field. Our solutions are purpose-designed for different crop systems. Connecting seeds and traits, crop protection products, digital tools and sustainability approaches, to help deliver the best possible outcomes for farmers, growers and our other stakeholders along the value chain. With teams in the lab, field, office and in production, we do everything in our power to build a sustainable future for agriculture. In 2023, our division generated sales of €10.1 billion.

For more information, please visit www.agriculture.basf.com or our social media channels.

Application process

1. Application

You found the job you like on our website. Time to hit that ‘apply’-button and let us know who you are through the application form.

2. First encounter

We are intrigued by your application and call you immediately. At this point you can expect questions like: What motivates you? And what are your skills?

3. Interview

The call went great! So here you are, ready for your interview with HR and a hiring manager. We want to know more of your story and of course, you can ask about our story as well.

4. Contract

Welcome to our team. When can you start? So we can everything ready for your first day. You know, computer, paperwork, cake, balloons …

5. Onboarding

We welcome you with open arms and get you up and running. Including our eye-opening bootscamp, from the lab to the field.