Key Duties And Responsibilities:
- People – Manage direct reports and provide guidance.
- Strategic – Work with the Senior validation team to generate the strategic direction for the department.
- Management - Ensure the correct allocation of validation resources. Support direct reports on site critical projects.
- Administration / Meetings – Departmental administration and performance management activities
Education and Experience
- Bachelor's (Level 8) Degree in Computer Science, Computer Engineering or related discipline.
- Thorough understanding and application of GMP and regulatory requirements.
- Advantage to have managed or supervised a team of experienced engineers in a similar industry
- Experience of wide range of validations including, Equipment, Cleaning, Sterilisation, Process Validation and in particular computer system validation.
- At least 5 years experience ideally within the clinical, the medical, the laboratory or the pharmaceutical industry.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilization, Packaging systems and related technologies.
- Good knowledge of Validations practices, corporate standards and relevant EU/FDA regulations. Self-sufficiency with a proven track record that demonstrates the ability to work under pressure.
- A strong understanding of current data integrity expectations would be a distinct advantage.
- Comfortable to take on large / complex projects containing multiple modules and multiple Vendors with interlinked systems.
For further information on this Validation Lead role in Galway please contact Karl Lippett on 086 1070950 / firstname.lastname@example.org
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