Junior Validation Engineer: Sterile Fill Finish Impact

Berkley Group; Dublin; On-site; EUR 40,000 - 60,000; Full time

Job summary

Berkley Group in Ireland is seeking a Junior Validation Engineer to support the Senior Validation Engineer, drafting and executing protocols and technical documents for sterile biotech equipment.

You will participate in the full validation lifecycle, develop URS, assist in change controls, liaise with engineering, QA and external vendors, and contribute to regulatory inspections. Eligibility to work in Ireland or EU passport required.

Qualifications

• 2+ years in science, engineering or validation.
• Technical degree in engineering or science.
• Experience managing commissioning & qualification for pharma/biotech projects.
• Experience with sterile/biotech equipment in pharma.
• Knowledge of GMP and environmental regulatory requirements.
• Ability to work in multidisciplinary site teams.

Responsibilities

• Provide expert validation support across the full lifecycle (design through validation maintenance).
• Assist in URS development and Quality Risk Assessments for equipment and automated systems.
• Assist in change controls to ensure validation standards are met.
• Coordinate with Engineering, Qualification, manufacturing, QA and external vendors on URS and FATs.
• Assist in developing and improving the equipment validation lifecycle to maintain compliance.
• Participate in regulatory inspections and filings.

Skills

Validation management

GMP knowledge

Cross-functional teamwork

Equipment validation

Sterile/biotech experience

Regulatory compliance

Education

Engineering or science degree

Job description

Berkley Group in Ireland is seeking a Junior Validation Engineer to support the Senior Validation Engineer, drafting and executing protocols and technical documents for sterile biotech equipment.

You will participate in the full validation lifecycle, develop URS, assist in change controls, liaise with engineering, QA and external vendors, and contribute to regulatory inspections. Eligibility to work in Ireland or EU passport required.