Lead CSV Validation Engineer — NC (MES/PLC)

Valspec

Raleigh (NC)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

ESOP

Premium medical coverage

401(k) with company match

Job summary

Valspec is seeking a flexible Validation Engineer (CSV Lead) to drive validation strategy and SDLC documentation for Werum PAS-X MES and Fill/Finish systems in a North Carolina manufacturing setting. The role requires leadership and 5+ years in CSV within the pharmaceutical sector, with extensive experience validating MES, PLCs, SCADA, serialization, and compliance with FDA/EMA and 21 CFR Part 11.

Join a team focused on data integrity, validation deliverables, and collaboration with vendors to

Qualifications

Bachelor's degree in engineering or computer science.
Minimum of 5 years in CSV/validation within pharma/biopharma.
Experience validating MES/Fill/Finish systems with PLCs, SCADA, MES, and Serialization.
Strong knowledge of FDA/EMA regulations and 21 CFR Part 11.

Responsibilities

Develop validation strategies and plans for Werum PAS-X and PLC-based Fill/Finish systems.
Lead creation, review, and approval of validation deliverables and traceability matrices.
Oversee FAT/SAT and commissioning activities for BAS and Fill/Finish systems.
Collaborate with cross-functional teams for requirements gathering.
Maintain data integrity across the validation lifecycle.
Mentor and guide project teams on CSV principles.