Lead CSV Validation Engineer — MES, NC

Valspec; Makkah Region; On-site; SAR 412,448 - 524,934; Full time

Benefits offered by this job

Employee Stock Ownership Plan (ESOP)

Premium medical coverage

401(k) with company match

Tuition reimbursement

Competitive benefits package

Job summary

Valspec, a global provider of system validation and lifecycle services, seeks a Validation Engineer (CSV) to lead validation strategy for MES and related systems in a regulated life sciences environment in North Carolina.

You will develop validation plans, protocols and reports for Werum PAS-X, PLCs, SCADA, and serialization; oversee FAT/SAT; ensure data integrity; and mentor the project team in CSV best practices.

Qualifications

• Bachelor's degree in Engineering, Computer Science or related field.
• Minimum 5 years' CSV/validation experience in pharma/biopharma.
• Experience validating MES, PLCs, SCADA, and serialization.

Responsibilities

• Develop and execute validation strategies and plans for Werum PAS-X and PLC-based Fill/Finish systems.
• Lead creation, review and approval of validation deliverables and risk assessments.
• Oversee FAT, SAT, commissioning activities and ensure data integrity.
• Collaborate with cross-functional teams to gather and map validation requirements.
• Mentor team members on CSV principles and best practices.

Skills

CSV validation

MES validation

Regulatory knowledge

SDLC

GxP

Leadership

Education

Bachelor's degree in Engineering or CS

Tools

Werum PAS-X

Siemens PLCs

Allen-Bradley PLCs

AVEVA Wonderware SCADA

Job description

Valspec, a global provider of system validation and lifecycle services, seeks a Validation Engineer (CSV) to lead validation strategy for MES and related systems in a regulated life sciences environment in North Carolina.

You will develop validation plans, protocols and reports for Werum PAS-X, PLCs, SCADA, and serialization; oversee FAT/SAT; ensure data integrity; and mentor the project team in CSV best practices.