SAP Validation Consultant

NNIT

Metro Manila

Hybrid

PHP 900,000 - 1,200,000

Full time

7 days ago

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Benefits offered by this job

Competitive Compensation

13th Month Pay

Performance Bonus

Rice Subsidy

Clothing and Laundry Allowance

Medical Allowance

HMO

Life Insurance

Vacation Leaves and Sick Leaves

Emergency Loan

Year-End Gift

Wedding Gift

First Baby Gift

Breakfast once a week

Fruits, Snacks / Well-stocked pantry

Hybrid set up

Job summary

NNIT Philippines seeks a Validation Consultant to ensure CSV compliance for SAP S/4HANA, with focus on regulatory requirements and data integrity across the lifecycle. You will prepare validation plans, specifications, and protocols, supporting project milestones and reporting.

The role requires 3+ years in end-to-end CSV for SAP and strong knowledge of SAP modules, with SDLC and QA involvement in a fast-paced Life Sciences IT environment. Hybrid setup in the Philippines is available.

Qualifications

At least 3 years of experience performing end-to-end CSV activities for SAP S/4HANA.
Strong understanding of core SAP modules (MM, PP, QM, PM, EWM and SD).
Strong understanding of validation processes including creation of the deliverables and execution of protocols.
Experience in providing support to Manufacturing-IT and/or SDLC Management such as change, issue, incident, and release.
Good understanding of 21 CFR Part 11, EU Annex 11 and regulatory requirements.
Good knowledge of V-model/Agile delivery, ISPE GAMP5 guidelines.
Life Sciences, biotech or pharmaceutical experience.
Strong verbal and written communications skills.
Experience in presentation and basic knowledge in data analytics.
Ability to work independently and with teams in a dynamic environment.

Responsibilities

Proactively fulfill the role as Consultant in small to medium complex Life Sciences IT projects.
Independently author or review validation deliverables for SAP S/4HANA validation.
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 (Data Integrity/ER).
Participate in small to medium complex end-to-end validations.
Review projects and operations documentation to ensure process requirements meet the QMS.
Prepare and execute testing activities – IQ, OQ, PQ including deviation handling and reporting.

Skills

CSV for SAP S/4HANA

SAP modules MM/PP/QM/PM/EWM/SD

Validation processes & deliverables

Manufacturing-IT/SDLC Support

21 CFR Part 11 & EU Annex 11

V-model/ISPE GAMP5

Life Sciences/pharma experience

Communication skills

Presentation & data analytics

Independence & teamwork

Job description

The resource will act as a Validation Consultant either for the client or for NNIT. Key responsibilities are ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV), lifecycle procedures, manufacturing execution systems (MES), and data integrity requirements specifically for SAP.

The Validation Consultant is responsible for preparing validation plans, specifications, and qualification documentation, so the total IT delivery meet customer needs and regulatory requirements. The Validation Consultant will provide to project milestones and reporting.

Duties and Responsibilities:

Proactively fulfill the role as Consultant in small to medium complex Life Sciences IT projects.
Independently author or review validation deliverables for SAP S/4HANA validation.
Assist the Project/Program Manager, the Project Validation Lead, Quality Project Lead or Project Validation Manager with quality and risk management issues. Conduct risk management assessments/workshops, and provide input to validation and test strategies.
Contribute to quality activities for Computer System Validation (CSV) projects/activities (including areas related to Data Integrity/ER).
Participate in small to medium complex E-2-E Validations.
Review projects and operations documentation to ensure process requirements are met according to the controlling QMS.
Prepare and execute testing activities – IQ, OQ, PQ including deviation handling and supported reporting.

Qualifications:

At least 3 years of experience performing end-to-end CSV activities for SAP S/4HANA
Has a Strong understanding of core SAP modules (MM, PP, QM, PM, EWM and SD)
Has a Strong understanding of validation processes including creation of the deliverables and execution of protocols
Experience in providing support to Manufacturing-IT and/or SDLC Management such as change, issue, incident, and release
Good understanding 21 CFR Part 11, EU Annex 11 and regulatory requirements
Good knowledge of most phases of the V-model/Agile delivery methodology, and ISPE GAMP5 guidelines
Life Sciences, biotech or pharmaceutical experience
Strong verbal and written communications skills
Experience in presentation and has basic knowledge in data analytics
Ability to work independently and with teams at various levels in the organization.
Ability to work in a very dynamic environment with clear sense of urgency
Excellent organizational skills with strong attention to detail and accuracy.

Nice to have:

Experience in quality management of IT applications (ServiceNow, Trackwise) or infrastructure, preferably from working in the Life Sciences industry
Knowledge in HP ALM, Valgenesis or Kneat
ISPE/ECA GAMP5 training or certification
ISTQB Foundation Certification
SAFe Agile Foundation

WHO WE ARE

NNIT Philippines

NNIT Philippines builds on a decade of experience, and has a reputation for developing high quality enterprise level software solutions and support as a Microsoft Gold Certified Partner.

NNIT Philippines is an integrated part of NNIT's global IT service delivery, including specializations in the development and maintenance of enterprise and eGovernment software solutions as well as IT infrastructure operations including network and server operations for NNIT's customers around the world. The Manila based delivery center is part of NNIT's 24/7 Global Operations Centre setup and delivers services in close cooperation with NNIT's other centers in Denmark, China and the Czech Republic.

On top of the statutory benefits stipulated by the local law, NNIT DLSP employees enjoy the following benefits upon joining: