Sr. Manager-MSAT (Validation) (Saudi Arabia)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 22 hours agoStatus: Live

Job Summary

Lead the validation lifecycle for equipment, facilities, and utilities using a V-Model approach, including URS, FAT/SAT, IQ/OQ/PQ, requalification, and cleanroom qualification to ISO-14644 standards. Own calibration planning, Computerized System Validation (CSV) and compliance with 21 CFR Part 11, and manage EQMS activities (change control, deviations, CAPA, audits). Guide SMEs, coordinate cross-functionally, and drive continuous improvement, risk management, and data integrity (ALCOA+).

Location: Saudi Arabia

Workplace: Onsite

Employment Type: Full time

Job Function: Data Analytics & Business Intelligence

Seniority: Sr. Manager level

Key Responsibilities

•Manage the qualification/validation lifecycle for equipment, facilities, and utilities from URS through FAT/SAT, IQ/OQ/PQ, requalification, and ensure cleanroom qualification meets ISO-14644.
•Oversee calibration activities, including setting rational criteria and frequencies and managing outsourced calibrations.
•Ensure Computerized System Validation (CSV) compliance for quality control, manufacturing, and utilities-related software, including adherence to 21 CFR Part 11 for new critical systems.
•Manage EQMS quality compliance activities including change control, deviation investigations, CAPA, and audit management with validation/qualification expertise.
•Lead and coordinate validation SMEs, track product lifecycle status with cross-functional teams, manage validation document archiving/retrieval/distribution, and drive continuous improvement, risk management, and data integrity (ALCOA+).

Key Requirements

•Minimum 10–15 years of work experience in qualification and validation, with a bachelor’s in engineering (Mechanical/Electrical or Mechatronic) or a pharmacy degree/master’s in science/pharmacy.
•Comprehensive understanding of GMP, GDP, ISO 9001, and ISO 14001 requirements.
•Strong familiarity with regulatory guidelines such as FDA, WHO, and EU.
•Experience with audits, CAPA, risk management, and QMS systems.
•Excellent leadership and people management skills, plus analytical problem-solving and MS Office/electronic QMS proficiency.

Experience:10-15 years

Education:Bachelor's in Mechanical/Electrical/Mechatronic engineering; pharmacy

Skills:LeadershipPeople managementAnalytical thinkingProblem-solvingCommunicationAccountabilityInitiative-takingCollaborationDiligenceAdaptability

Tech Stack:V-ModelURSFATSATIQOQPQRequalificationISO-14644Utilities qualificationPurified WaterWater for injectionCompressed gasesNitrogen GasesClean room qualificationCalibrationComputerized System Validation (CSV)21 CFR Part 11EQMSChange Control

Company Brief

Julphar

Website

Loading job details...

Preparing the role view and application actions.

Julphar

2 days ago

Sr. Manager-MSAT (Validation) (Saudi Arabia)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 22 hours agoStatus: Live

Job Summary

Location: Saudi Arabia

Workplace: Onsite

Employment Type: Full time

Job Function: Data Analytics & Business Intelligence

Seniority: Sr. Manager level

Key Responsibilities

•Manage the qualification/validation lifecycle for equipment, facilities, and utilities from URS through FAT/SAT, IQ/OQ/PQ, requalification, and ensure cleanroom qualification meets ISO-14644.
•Oversee calibration activities, including setting rational criteria and frequencies and managing outsourced calibrations.
•Ensure Computerized System Validation (CSV) compliance for quality control, manufacturing, and utilities-related software, including adherence to 21 CFR Part 11 for new critical systems.
•Manage EQMS quality compliance activities including change control, deviation investigations, CAPA, and audit management with validation/qualification expertise.
•Lead and coordinate validation SMEs, track product lifecycle status with cross-functional teams, manage validation document archiving/retrieval/distribution, and drive continuous improvement, risk management, and data integrity (ALCOA+).

Key Requirements

•Minimum 10–15 years of work experience in qualification and validation, with a bachelor’s in engineering (Mechanical/Electrical or Mechatronic) or a pharmacy degree/master’s in science/pharmacy.
•Comprehensive understanding of GMP, GDP, ISO 9001, and ISO 14001 requirements.
•Strong familiarity with regulatory guidelines such as FDA, WHO, and EU.
•Experience with audits, CAPA, risk management, and QMS systems.
•Excellent leadership and people management skills, plus analytical problem-solving and MS Office/electronic QMS proficiency.

Experience:10-15 years

Education:Bachelor's in Mechanical/Electrical/Mechatronic engineering; pharmacy

Skills:LeadershipPeople managementAnalytical thinkingProblem-solvingCommunicationAccountabilityInitiative-takingCollaborationDiligenceAdaptability

Company Brief

Julphar

Website