Validation Engineer - Junior

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

Global Biotechnology company looking for Validation Engineer - Junior. The successful candidate will be supporting Senior Validation Engineer, working on drafting, executing protocols and technical documents. Leasing with validation team, involve on SAT, FAT, risk assessments. This role will be responsible for equipment validation in Sterile Fill Finish to ensure the maximum levels of performance and compliance are maintained.

The Job:

• Provide expert technical validation support to meet site objectives, comprising of the full validation life-cycles process from initial design through qualification to validation maintenance (e.g. Periodic review).
• Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
• Assist in assessment of project change controls ensuring Validation standards & requirements is met.
• Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Assist in the development and improvements of the equipment validation life-cycle process while ensuring continued compliance to all necessary regulations.
• Participate in regulatory inspections, regulatory filings and RTQ's (response to questions).

Have You:

• 2+ year's experience in Science, Engineering or Validation, Commissioning and Qualification Management.
• Technical qualification at third level or equivalent in Engineering or science.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Participate, when required, as a member of a multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team or NPI regulatory marketing applications.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.