Leading Process Equipment and Validation Specialist

4 days ago

Dundalk, Louth, Ireland beBeeProcessEngineering Full time €120,000 - €140,000
Process Equipment and Validation Leader

This is a key leadership role for an experienced professional with expertise in process equipment and validation lifecycle management.

As the Process Equipment and Validation Leader, you will be responsible for overseeing the lifecycle of process equipment and validation at our site. This includes project delivery, qualification/validation, ongoing requalification/revalidation, and system retirement.

The successful candidate will have:

  • Proven experience establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments.
  • Expertise in process equipment and validation lifecycle management within a regulated biotech/biologics environment.
  • Knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements (EMA, FDA).
  • Familiarity with ASME BPE, ISPE, EHS standards, and Quality Systems.

Key Responsibilities:

You will lead on-site engineering activities to ensure alignment with GMP, GDP, data integrity (ALCOA+), corporate standards, and global regulatory requirements. You will also serve on the Engineering Leadership Team to contribute to site strategy, operational planning, and cross-functional decision-making.

Requirements:

The ideal candidate will have:

  • A proven track record of establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments.
  • Expertise in process equipment and validation lifecycle management within a regulated biotech/biologics environment.
  • Strong knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements.
  • Familiarity with ASME BPE, ISPE, EHS standards, and Quality Systems.

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