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

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

medical device industry.

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

validation lifecycle management, including

IQ, OQ, PQ, FAT, and SAT.

Proven expertise in

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.