MES Validation Specialist (Hybrid)

Nnit A/S; Makati; Hybrid; PHP 670,000 - 1,339,000; Full time

Benefits offered by this job

Competitive compensation

13th month pay

Performance bonus

Rice subsidy

HMO (Employee and Dependent)

Job summary

NNIT Philippines is seeking a Validation Consultant to support Life Sciences IT projects, ensuring regulatory compliance, CSV lifecycle adherence, and data integrity across validation activities.

You will prepare Validation Plans, Specifications, IQ/OQ/PQ testing, and contribute to risk management and quality activities, collaborating with project teams to meet customer needs and regulatory requirements.

Qualifications

• At least 2 years of experience in a Consultant/Quality role.
• Experience working with validated computer systems (CSV).
• Experience validating MES such as PAS-X, MODA-ES, Syncade, CAMSTAR, and other MES software.
• Experience in GxP and Quality Management.
• Experience supporting manufacturing-IT and SDLC management (change, issue, incident, release).
• Strong understanding of GAMP5, ICH Q7/Q9, 21 CFR Part 11, EU Annex 11 and regulatory requirements.
• Good knowledge of the V-model/Agile delivery and ISPE GAMP5 guidelines.
• Experience creating and reviewing documentation.
• Life Sciences, biotech or pharmaceutical experience.
• Strong verbal and written communication skills.
• Ability to work independently and with teams at various levels.
• Ability to work in a dynamic environment with urgency.
• Excellent organizational skills and attention to detail.

Responsibilities

• Proactively fulfill the role as a Validation Consultant in small to medium Life Sciences IT projects.
• Independently prepare validation documents.
• Assist the Project/Program Manager, the Project Validation Lead, Quality Project Lead, or Project Validation Manager with quality and risk management issues; conduct risk assessments/workshops and provide input to validation and test strategies.
• Contribute to Quality Activities for CSV projects, including Data Integrity/ER.
• Participate in small to medium complex end-to-end Validations.
• Review projects and operations documentation to ensure process requirements are met per the QMS.
• Identify and implement process improvements.
• Prepare testing activities – IQ, OQ, PQ including deviation handling and reporting.

Skills

Regulatory compliance

CSV knowledge

Data integrity

GxP experience

MES systems experience

Quality assurance

Documentation skills

Job description

NNIT Philippines is seeking a Validation Consultant to support Life Sciences IT projects, ensuring regulatory compliance, CSV lifecycle adherence, and data integrity across validation activities.

You will prepare Validation Plans, Specifications, IQ/OQ/PQ testing, and contribute to risk management and quality activities, collaborating with project teams to meet customer needs and regulatory requirements.