Tech Transfer Validation Interface Engineer

LSC, Life Science Consultants

Munster

On-site

EUR 60,000 - 90,000

Full time

21 hours ago

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Job summary

LSC Life Science Consultants seeks a Technology Transfer Engineer - Validation Interface to bridge Tech Transfer/NPI with the CQV/Validation function in a GMP environment. You will translate transfer requirements into validation protocols and QRAs, coordinate equipment readiness, and support a master schedule integrating transfer and validation activities.

The successful candidate has 3+ years in CQV/validation within pharma, strong knowledge of document hierarchies and EU GMP Annex 1 (2022) and

Qualifications

Minimum of 3+ years' experience in CQV/validation within GMP pharma.
Strong knowledge of document hierarchy (Master Plan, QRA, Protocol, Report).
Excellent understanding of EU GMP Annex 1 (2022) and ICH Q9(R1) risk-based qualification.
Proven ability to coordinate cross-functional teams and manage validation deliverables.
Strong organizational skills with the ability to elevate schedule conflicts promptly.

Responsibilities

Act as the dedicated interface between Tech Transfer/NPI and CQV/Validation.
Translate transfer requirements into validation protocols and QRAs with validation teams.
Coordinate equipment and utility readiness, ensuring qualification statuses support transfers.
Track validation dependencies and elevate scheduling conflicts within the CQV delivery matrix.
Support the maintenance of a master schedule that integrates transfer and validation activities.