MES Validation Consultant (Manufacturing Execution System)

About the Role/Project

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, and data integrity requirements.

The Validation Consultant is responsible for preparing Validation Plans, Specifications, and Qualification documentation, so the total IT delivery meets customer needs and regulatory requirements. The Validation Consultant will provide input to project milestones and reporting.

Duties and Responsibilities:

• Proactively fulfill the role as a Validation Consultant in small to medium complex 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 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.
• Identify and implement process improvements.
• Prepare testing activities – IQ, OQ, PQ including deviation handling and supported reporting.

Qualifications:

• At least 2 years of experience working in a Consultant/Quality role
• Experience working with validated computer systems (CSV)
• Experience validating Manufacturing Execution Systems (MES) such as PAS-X, MODA-ES, Syncade, CAMSTAR, and other software related to MES
• Experience in GxP and Quality Management
• Experience in providing support to manufacturing-IT and/or SDLC management such as change, issue, incident, and release
• Good understanding of GAMP5, ICH Q7/Q9, 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
• Experience with 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 in the organization
• Ability to work in a very dynamic environment with a 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
• Understanding of Manufacturing Execution System(PAS-X and MODA-EM)
• SAFe Agile Foundation

WHO WE ARE

NNIT is a leading provider of IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark.

We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high.

We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers.

We strive to build unmatched excellence in the industries we serve, and we use our domain expertise to represent a business first approach – strongly supported by a selection of partner technologies, but always driven by business needs rather than technology.

NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,700 people in Europe, Asia and USA.

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:

• Competitive compensation
• 13th month pay
• Performance bonus (discretionary)
• Rice subsidy
• Communication allowance
• Clothing and laundry allowance
• Medical allowance (Employee and Dependent)
• HMO (Employee and Dependent/s)
• 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

Related positions:

Commissioning, Qualification and Validation Engineer (CQV Engineer)

Computer System Validation Engineer / Computerized System Validation Engineer (CSV Engineer)

Process Engineer

Quality Assurance Engineer / QA Engineer

Validation Engineer / Validation Specialist

Software Validation Engineer

Software Testers / Software Engineer

System Engineer / System Validation Engineer

Notes:

1. By applying to this job ad, you acknowledge and agree for your information to be collected by NNIT. Rest assured, any information you share will only be used for recruitment/hiring purposes.

2. This position is available only to those with current authorization to live and work in the Philippines.