General information

Publication date

02/07/2025

Position description

Job title

CSV & DI Squad Lead

Contract

Permanent contract

Job description

About the Role

We are currently seeking a CSV & Data Integrity (DI) Squad Lead. In this role, you will co-lead, together with Local Process Owners, the effort to align all CSV and DI initiatives at the site with current industry best practices. This includes the dimension of risk management.

Key Responsibilities

Provide expert guidance on CSV and DI best practices, ensuring alignment with modern risk-based approaches
Oversee multiple projects, including managing external resources (contractors), ensuring timely and effective delivery
Ensure quality and regulatory in collaboration with the corresponding QA lead to assure full alignment
Lead change management efforts to embed best practices across the organization
Coach and mentor Local Process Owners to elevate their knowledge and implementation of industry best practices

Business Industry

Life sciences

Profile

Strong expertise in CSV and DI within a pharmaceutical manufacturing context
Experience with API environments preferred
Familiarity with systems such as DeltaV, PI, PCS7 along with practices as effective alarm management
In-depth knowledge of FDA and EMA requirements related to CSV and DI
Practical experience with risk-based validation and the preparation of validation documentation
Proven project management abilities: planning, coordination, and delivery
Strong interpersonal and communication skills
Experience in leading teams in complex and dynamic environments
Skills in coaching, training, and human change management
Ability to navigate organizational dynamics and influence without formal authority
Fluent in English, both written and spoken, Dutch is a plus

Position location

Job location

Europe, Belgium

Location

Noordkustlaan 16B 1702 Dilbeek

Candidate criteria

Level of experience

3 to 5 years

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