Validation Laboratory Equipment

Industry

Engineering Services

Category

Quality Assurance & Test

Experience

Mid level

Applications are considered on a rolling basis

**Location**: Multiple locations

**Workspace type**: Hybrid

Follow Capgemini Engineering

Contact Person
Chloé Olivet

**Job Description**:
Your role

You will give quality assurance oversight on (IQOQ / PQ ) protocols and reports

You will help define and support the Validation Approach

You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR)

You will review CSV specific SOP’S and Templates

You will perform risk assessments

You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments,)

You will make sure that production practice are aligned with validation conclusion

You will communicate to management about issues in the validation process

You will attend project meetings

You will provide QA oversight and approve deviation

You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process

You will define validation strategies through the change control process

You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review,.)

You will support the production, QA and technical service teams in the implementation of validation activities

You will work in close collaboration with production, engineering, maintenance, QC, QA

**Profile**:
Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains

French or Dutch fluent and fluent in English

A minimum relevant experience of 2 years in the (bio)pharmaceutical sector in a computer systems validation role

Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus

Good interpersonal relationship skills

Problem solving and achievement oriented

Be a good team player in order to succeed in each validation project

Be able to use a risk-based approach for problem solving and prioritization of tasks

LI-CO2

About the company

Since 2020, Capgemini Engineering (formerly Altran) has been an integral part of Capgemini, a global leader in consulting, digital transformation, technology and engineering services. As a part of the Capgemini family and a global leader in engineering and R&D services, we bring the most powerful innovation for Intelligent Industry to the world of tomorrow: on the road, in the air, on the seas, in rail transport, in energy production, in life science, finance and telecommunications. We have more than 52,000 engineers and scientists in over 30 countries. Our mission to develop technology for an inclusive and sustainable future requires one thing above all: human energy We want to grow. Are you a technology enthusiast, ambitious and would you like to be a part of something big? Are you the ONE for Capgemini Engineering?