Technology Transfer Engineer - Validation Interface
Are you ready to play a pivotal role in streamlining technology transfer processes within the pharmaceutical industry? We are seeking an experienced and proactive Technology Transfer Engineer - Validation Interface to become a vital link between technical transfer teams and validation functions. This dynamic role offers a unique opportunity to ensure seamless transfer requirements are accurately translated into validation deliverables, supporting efficient project execution and compliance in a GMP environment. Join us in driving innovation and quality in life sciences manufacturing!
Key Responsibilities:
- Act as the dedicated interface between the Tech Transfer/NPI team and the CQV/Validation function
- Translate transfer requirements into validation protocols and QRAs in collaboration with validation teams
- Coordinate equipment and utility readiness, ensuring prior qualification statuses support product transfers
- Track and report validation dependencies and escalate scheduling conflicts within the CQV delivery matrix
- Support the maintenance of a comprehensive master schedule that integrates transfer and validation activities
Required Skills:
- Minimum of 3+ years' experience in CQV/validation roles within a GMP pharmaceutical environment
- Strong knowledge of the site's document hierarchy (Master Plan, QRA, Protocol, Report) or equivalent validation frameworks
- Excellent understanding of EU GMP Annex 1 (2022) and ICH Q9(R1) risk-based qualification principles
- Proven ability to coordinate cross-functional teams and manage validation deliverables effectively
- Strong organizational skills with the ability to escalate and resolve scheduling conflicts promptly
Preferred Education and Experience:
- Degree in a scientific or engineering discipline
- Experience working across two functions or programmes with distinct scopes (e.g., CQV and NPI or CQV and Manufacturing)
- Prior hands-on experience with equipment/utility qualification for sterile fill-finish operations, including isolators, RABS, lyophilisers, autoclaves, and WFI/clean steam systems
Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Apply via this advert or contact Siobhan Cummins on 021 4777329 if you have any questions about this role. Find out more about working with LSC at lscconnect.com
