The Squad Lead for Cleaning Validation & Cleaning Operations has the responsibility to co-lead (in partnership with the local process owners) the effort to bring all existing cleaning validation and cleaning operations efforts on our Geel site in line with current industry best practices (including the dimension of risk management). On-site presence is required for min 80%.
As a Squad Lead you will...
* Provide direction on cleaning validation and operations best practices, with science-based risk management approaches
* Oversee projects and contractor resources, ensuring delivery against plan using strong project management controls
* Assure quality and compliance of all deliverables in partnership with the QA lead
* Lead change management initiatives to embed best practices across the organisation
* Mentor and coach the Local Process Owner to uplift knowledge to industry-leading standards
As a Squad Lead you must...
* Have deep expertise in equipment cleaning and cleaning validation in a pharma manufacturing environment (API experience preferred)
* Understand FDA and EMA requirements, with hands-on experience in risk-based approaches and validation document creation
* Bring excellent project management, organisational, and coordination skills
* Demonstrate strong interpersonal and communication skills, with experience leading teams in complex environments
* Possess coaching, change management, and training skills
* Be able to navigate organisational politics, influence without authority, and interact at all levels
* Speak English (and Dutch is a plus)