Process Validation Engineer
- Ireland, Dublin
- Contract
- Commissioning, Qualification and Validation
Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Process Validation Engineer to support the company.
Process Validation Engineer responsibilities:
- Support the development and implementation of scientifically sound, fit for purpose Validation and TT guidance based on current regulations, industry standards and industry practices.
- Drive innovative and efficient approaches to Validation and TT incorporating science and risk-based approach.
- Support the ATO team to continuously improve Validation and TT practice across the network using a lean and standardised approach that can be replicated and continuously improved for subsequent product transfers.
- Support the development of Validation and TT process tools including TT templates, tracking tools, knowledge management tools e.g. Smart Sheet and potentially other digital solutions to support driving necessary TT Process improvements.
- Work closely with other members of the ATO Validation and TT team on implementation of business improvements.
Requirements as a Process Validation Engineer
- A minimum of 7 years’ progressive experience the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services or Quality).
- Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
- Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
- Strong track record of working in a global and matrix environment, working cross functionally.
- Experience in developing and using Smart Sheet as a tracking solution an advantage.
- Experience in Kneat Digital validation solutions an advantage.
If this role is of interest to you, please apply now!
#LI-TE1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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