This organisation focus on developing and delivering innovative medicines for patients with rare diseases and other specialty conditions. This might be a therapy to treat an extremely rare and life-threatening disease such as Hunter syndrome or Fabry disease, or a medicine for a specialist condition such as ADHD or ulcerative colitis. This dynamic organization are currently looking for a Validation Engineer to join their team.
- Developing Validation Documentation (e.g. specifications, plans, protocols, procedures) to support cold chain / controlled temperature transportation and new process/product introductions to support supply continuity and process improvement requirements.
- Providing technical input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
- Review and approval of documents prepared by the validation team, other departments and contractor organisations.
- Responsible for Commissioning and Qualification documentation generation, review and approval, where appropriate including: Validation Project Plans, FMEAs/Risk Assessments, Functional Design Specification, Factory Acceptance testing, Site Acceptance Testing, IQ, OQ and PQ protocols and reports, Investigations, Commissioning Test Plans, and User Requirement Specifications as applicable.
- Resolving and assisting in the closure of deviations initiated during qualification execution.
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
- Co-ordinate qualification activities with contractors and vendors as required.
The successful encombant will have a 3rd Level Qualification, B.Sc. or M.Sc. in chemical/biochemical engineering or related field with validation experience in the biotech/pharma industry. 4 years validation experience in a similar industry is essential. Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle and quality systems, cGMPs, GDPs and FDA/EMEA guidelines and proven ability to apply guidelines to all aspects of qualification activities.
To learn more apply online or contact Preneta Naidoo on +353 1 6321870.
Salary: On Application
Location: Dublin West