Technology Transfer Engineer - Validation Interface

LSC, Life Science Consultants; Munster; On-site; EUR 60,000 - 90,000; Full time

Job summary

LSC Life Science Consultants seeks a Technology Transfer Engineer - Validation Interface to bridge Tech Transfer/NPI with the CQV/Validation function in a GMP environment. You will translate transfer requirements into validation protocols and QRAs, coordinate equipment readiness, and support a master schedule integrating transfer and validation activities.

The successful candidate has 3+ years in CQV/validation within pharma, strong knowledge of document hierarchies and EU GMP Annex 1 (2022) and

Qualifications

• Minimum of 3+ years' experience in CQV/validation within GMP pharma.
• Strong knowledge of document hierarchy (Master Plan, QRA, Protocol, Report).
• Excellent understanding of EU GMP Annex 1 (2022) and ICH Q9(R1) risk-based qualification.
• Proven ability to coordinate cross-functional teams and manage validation deliverables.
• Strong organizational skills with the ability to elevate schedule conflicts promptly.

Responsibilities

• Act as the dedicated interface between Tech Transfer/NPI and CQV/Validation.
• Translate transfer requirements into validation protocols and QRAs with validation teams.
• Coordinate equipment and utility readiness, ensuring qualification statuses support transfers.
• Track validation dependencies and elevate scheduling conflicts within the CQV delivery matrix.
• Support the maintenance of a master schedule that integrates transfer and validation activities.

Skills

CQV/Validation

GMP knowledge

EU GMP Annex 1

ICH Q9(R1)

Cross-functional coordination

Schedule management

Education

Science or Engineering Degree

Job description

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 elevate 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 elevate schedule 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.

Find out more about working with LSC at lscconnect.com