Process Validation Specialist

☞ Takeda

看过: 215

更新日: 26-11-2025

位置: Lessines Hainaut

类别: 质量保证/质量控制

行业: Financial Services Biotechnology Pharmaceuticals

水平: Entry level

工作类型: Full-time

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工作内容

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Job Description

The Lessines Process Validation Specialist, part of the Lessines MS (Manufacturing Sciences) organization, is responsible for providing the expertise and support for the manufacturing process qualification/validation projects at Takeda Lessines’ production facility (Purification, Filling and Packaging). He/She will be accountable for the preparation, implementation and documentation of the validation activities required to assure the proper development of a project in accordance to local and global PV strategies while ensuring and maintaining the appropriate validation state of Lessines’ Production Processes. He/she manages deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon. He/she will support the regulatory submissions and audits related to the process qualification/validation projects.

Job Function and Description

Acts as a validation representative for small, mid size and big Process Validation projects within the plant:
  • Defines, prepares and implements all validation activities related to the project.
  • Develops the Validation Plans: defines and documents validation methodology and approach. Submits to the Validation Lead for review.
  • Provides validation expertise for the development of the project.
  • Participates in the risk assessment related to the project.
  • Participates in URS, FS and DS definition and writing
  • Prepares and implements FAT, IQ, OQ & PQ protocols.
  • Assures requirements traceability throughout the whole project validation file (from URS to PQ).
  • Organizes and coordinates FAT, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) in such a way that all of them concur with the timeframes committed with the project leader.
  • Analyzes, interprets, documents and reports the testing results.
  • Ensures the follow-up and tracking of the validation activities. Updates the validation documentation system.
  • Assures feedback of status and issues to the Validation Lead
Closely collaborates with the PV stakeholders (MS, MQ, production, quality, regulatory, business excellence) to ensure continuous improvement (e.g. process robustness) by controlling the critical PV life cycle from process development, validation, authory submission to routine production

Secures that the process validation status is continuously maintained, following the established local and global PV strategies

Ensures compliance with current GMP and other regulatory requirements and supports corresponding regulatory submission writing and (oral) defenses during regulatory audits

Contributes to international standardization for topics related to process validation

Provides support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

Assures the ability to meet the Department goals with respect to EHS, Quality, Compliance, Supply and Budget fullfilment

Coordinates activities of junior validation engineers and contractors

Education And Experience Requirements

BS or Master Degree in Engineering, Chemistry, Life Science, or other job related discipline or equivalent by experience

At least 2 years professional experience in Validation/Quality systems or similar role

Knowledge, skills and ability
  • Knowledge of Process Validation Methodologies
  • Knowledge of manufacturing processes and expertise in biochemistry, protein purification, filling and engineering principles
  • Knowledge of risk assessment tools
  • Knowledge of data analytics and problem solving methodologies
  • Project management experience
  • Knowledge of quality systems, regulations, cGMP, GDP
  • Excellent verbal and written communication skills (English)
  • High level of customer orientation
  • Flexible in mind / out of the box thinker
Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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最后期限: 10-01-2026

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