Sr. Validation Engineer in Haarlem

Engineering

Netherlands, Haarlem

Fulltime

V--1

Competitive

Are you ready to make a meaningful impact in the pharmaceutical industry? The company is a global leader in generic drugs and biopharmaceuticals, is looking for a highly skilled and experienced Senior Validation Expert to join our team in Haarlem. Our simple and straightforward approach aims to provide patients with more flexible and affordable solutions, improving lives worldwide for over a century.
 
Overview
As a Senior Validation Consultant, you will play a crucial role in validating and re-qualifying Equipment/Systems, including Project work, Changes, and CAPAs. Your expertise in steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies within the pharmaceutical industry will be essential. Ensure compliance with regulatory requirements, optimize operational efficiency, and uphold product quality.
 
Key Responsibilities

Lead and participate in equipment qualification activities (IQ, OQ, PQ).

Execute validation protocols/plans for steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies.

Document, notify, and coordinate corrective actions for deviations.

Provide technical expertise and guidance on validation-related issues.

Collaborate with cross-functional teams to align validation activities with production schedules and quality expectations.

Conduct risk assessments and propose mitigation strategies.

Draft, review, and assess validation data, deviations, and change controls.

Ensure adherence to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).

Support internal/external inspections/audits and represent relevant topics as an SME.

Mentor and provide training to junior validation team members.

 
Qualifications

Bachelor’s or higher degree in a relevant scientific or engineering discipline.

Minimum 4-5 years of experience in validation/CQV within the pharmaceutical industry.

Knowledge of GMP, V-Model & SDLC methodologies.

Strong analytical, problem-solving, organizational, and project management skills.

Team player with attention to detail and a strong can-do mentality.

Excellent written and verbal communication skills.

 
What We Offer
Competitive market-based salary with attractive secondary benefits.
 
Start Date
1st February
 
Contract
1 year (temporary)
 
Hours
Fulltime
 
If you are a detail-oriented team player with a can-do mentality and the required experience, we invite you to apply for this exciting opportunity.