Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)

Macpower Digital Assets Edge; Fayetteville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in automation projects seeks a Validation Lead to oversee validation activities across significant capital automation initiatives in relation to medical devices. The ideal candidate will possess over 5 years of experience, ensuring compliance with industry regulations and standards. This role involves leading documentation efforts and collaborating with teams to assure compliance and quality in validation processes.

Qualifications

• Minimum 5 years of experience leading validation of capital automation projects.
• 4-7 years in medical device industry regulations.
• Knowledge of IQ, OQ, PQ, FAT, SAT.

Responsibilities

• Lead validation activities for major capital automation projects.
• Develop and execute validation protocols (IQ, OQ, PQ).
• Ensure compliance with regulatory standards (FDA, ISO).

Skills

Validation

Compliance

Technical writing

Problem-solving

Tools

SCADA

SAP

Job description

Job Summary : We are seeking an experienced

Validation Lead to oversee the validation of major capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with SCADA and SAP systems. A background in the medical device industry is preferred.

Key Responsibilities :

Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.

Develop and execute validation protocols, including

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Ensure adherence to

GxP guidelines such as

Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).

Maintain compliance with regulatory standards, including

FDA 21 CFR Part 11, ISO 9001, ISO 13485 (for medical devices), and ISO / IEC 27001 (for information security).

Oversee

Computer System Validation (CSV) processes, including risk-based validation, system integration, interface testing, and data integrity assessments.

Collaborate with cross-functional teams to validate automation systems, including

SCADA and SAP.

Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.

Ensure compliance with regulatory requirements specific to the

Required Qualifications :

Minimum

5 years of experience leading the validation of major capital automation projects.

4-7 years of experience in the

medical device industry and associated regulations.

Strong knowledge of

IQ, OQ, PQ, FAT, and SAT.

Computer System Validation (CSV), including software testing, system integration, and documentation.

Familiarity with

SCADA and SAP for system validation.

Excellent technical writing and documentation skills.

bility to work in a regulated environment and ensure compliance with industry standards.

Preferred Qualifications :

Experience in

medical device industry validation.

In-depth understanding of risk-based validation methodologies.

Strong problem-solving and analytical skills.

bility to lead and mentor teams in validation activities.

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Validation Engineer • Fayetteville, NC, United States

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