Qualification & CSV Validation Consultant

Job Title: Qualification & CSV Validation Consultant

Rate: Competitive in line with skills / experience

Type: Consultant

My client, a global organisation are seeking a highly skilled
Qualification & Validation Engineer
with deep expertise in pharmaceutical equipment and system validation, including
CSV
and
data integrity
. This critical role offers the opportunity to contribute to major pharmaceutical projects by ensuring the highest standards of regulatory compliance, process efficiency, and operational excellence.

You\’ll play a key role in supporting cross-functional project teams, overseeing validation efforts, and driving continuous improvement in line with cGMP and international regulatory requirements.

Responsibilities

Act as departmental representative in
project kick-offs
and follow-up meetings

Draft, update, and manage
qualification and validation documentation
, including:

• Qualification/Validation Plans (QP/VP)
• Protocols and Reports (DQ, FAT/SAT, IQ, OQ, PQ/VAT)
• Traceability Matrices (TM)

Plan and execute qualification/validation tests (FAT/SAT/IQ/OQ/PQ)

Coordinate activities with
external service providers
for initial validations

Manage deviations according to internal systems during qualification phases

Maintain and monitor department
performance indicators (KPIs)

Contribute to
process improvement initiatives
to optimize cost and efficiency

What We\’re Looking For

• Engineering degree or equivalent
• Proven experience in qualification of automated & computerized pharmaceutical equipment
• Solid experience in CSV & data integrity (21 CFR Part 11, GAMP)
• In-depth experience with equipment such as filling lines, packaging, track & trace systems, and biotech platforms
• Strong understanding of
  cGMP validation practices
• Fluency in both French and English required
• Familiar with validation of global IT/OT systems:
• Global Data Historian
• Cybersecurity systems
• GLIMS releases
• TrackWise

Interested? Apply now for immediate consideration or contact Michael Owusu-Ansah on – mowusu–

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