GMP Validation Engineer: Change Control & PQ Lead

Nalys; Waals-Brabant; On-site; EUR 60,000 - 85,000; Full time

Job summary

Nalys is seeking a Validation Engineer to join its Manufacturing Science & Technology (MSAT) organization for a leading global biopharma client in Belgium. You will drive validation projects from kick-off to completion, from equipment qualification to process validation, in a GMP-regulated environment.

You will collaborate with production, quality, QC and engineering stakeholders, ensuring timely delivery and robust change control, IQ/OQ/PQ execution, and risk assessments for validated

Qualifications

• Minimum 3 years of experience in a pharmaceutical environment, within quality and validation.
• IQ/OQ/PQ validation experience and related documentation.
• Strong knowledge of GMP requirements related to validation activities.

Responsibilities

• Managing validation projects: presenting projects and escalating status in internal governance, organizing kick-offs, planning and follow-up, and managing stakeholders
• Coordinating the change control process for short-, mid- and long-term projects
• Assessing the validation impact of changes through the electronic change control system and owning the related tasks
• Writing and reviewing IQ/OQ protocols and reports to ensure equipment qualification
• Supporting the team in the creation of risk analyses
• Writing and reviewing equivalence certificates
• Designing the validation strategy and writing PQ protocols in line with company standards and procedures
• Ensuring PQ readiness and coordinating validation activities
• Acting as the main point of contact with Quality Control.

Skills

Validation experience

Project management

GMP knowledge

French & English fluency

Teamwork in matrix environment

Proactive & organized

Education

Bachelor's degree in Biotechnology/ Chemistry/ Pharmacy or related

Job description

Nalys is seeking a Validation Engineer to join its Manufacturing Science & Technology (MSAT) organization for a leading global biopharma client in Belgium. You will drive validation projects from kick-off to completion, from equipment qualification to process validation, in a GMP-regulated environment.

You will collaborate with production, quality, QC and engineering stakeholders, ensuring timely delivery and robust change control, IQ/OQ/PQ execution, and risk assessments for validated