Spclst, Operations, Tech Supply

EyeBio

Dunboyne

On-site

EUR 90,000 - 120,000

Full time

5 days ago
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Benefits offered by this job

Hybrid work model
Equal opportunity employer

Job summary

EyeBio in Dunboyne, Ireland, seeks a Spclst, Operations, Tech Supply SME with 4–5 years in Pharmaceutical Microbiology/Virology to support method verification/suitability and transfer across the network, including the Dunboyne site.

You will lead evaluation of alternative microbiology methods, provide technical transfer support, author regulatory source documents, and travel to network sites as needed (≈10%).

Qualifications

  • 4–5 years in Pharmaceutical Microbiology/Virology.
  • Bachelor’s degree required; Masters may be advantageous.
  • Strong project management and GMP knowledge.

Responsibilities

  • Provide SME input for microbiological/virological methods during transfer, verification, and qualification.
  • Support regulatory filings with source documents and method development.
  • Lead or participate in multidisciplinary teams solving technical problems.
  • Travel to network sites up to 10% of time to support implementations and investigations.

Skills

Data Analytics
Driving Continuous Improvement
Manufacturing Quality Control
Method Validation
Method Verification
Process Optimization
Technical Transfer

Education

Bachelor’s Level 8 Degree
Masters desirable

Job description

Job Description

A fantastic opportunity has arisen for a Spclst, Operations, Tech Supply.

The individual is a Subject Matter Expert (SME) role for one or more microbiological/virological methods. As an SME, the individual will have an important role in supporting the method verification/method suitability of microbiological/virological methods for one or more commercialized products and provide training to the network.

Their responsibilities encompass ensuring the proper introduction and qualification of microbiological/virological methods by the receiving unit (including Dunboyne site) during the transfer process in accordance with applicable guidelines.

On an as-needed basis, the Specialist provides practical and scientific support for alternative microbiological technology (Rapid Microbiology Methods), microbiological studies and investigations supporting the Dunboyne site and/or network sites. This means that the SME offers both technical expertise during these processes and travels as required for at least 20% of their time.

Bring energy, knowledge, innovation to carry out the following:
  • Microbiological / Virological SME of at least two method / technique, with a scientific understanding of the microbial /virological techniques used in pharmaceutical industry.
  • Responsible for best scientific practices within the lab space and supports from a microbiological perspective, troubleshooting, network and life cycle management activities in the Dunboyne site as well as for the network.
  • Supports the implementation of microbiological methods (compendial/alternative microbiological methods) in a harmonized way to secure efficient implementation at the receiving unit (internally and/or externally).
  • Provides scientific and practical support to analytical investigation during method suitability and routine use.
  • Provides practical support for microbiological tests on an as-needed basis for methods and studies in their expertise for the transfer and commercialization of Biologicals/Vaccines.
  • Participates as a SME in the evaluation, method development, method validation of alternative microbiological technology (Rapid Microbiology Methods).
  • Responsible for authoring primary and secondary source documents used for regulatory filings.
  • Project Member and/or lead.
  • Support the implementation of microbiological methods at receiving units.
  • Supports as SME the Dunboyne QC-Micro and AS&T team.
  • Participates in Root Cause Analysis as SME for significant investigations.
  • Participates as SME in multidisciplinary teams solving technical problems at global or multisite level.
  • Participates in global change control processes as an SME or as change owner.
  • Takes GMP requirements into account when setting up experiments and protocols.
  • Ensures compliance of protocols, lab data and reports.
  • Ensures safety at personnel and at lab level.
What skills you will need:
  • Bachelor’s Level 8 Degree, Masters is desirable or equivalent through experience.
  • Minimum of 4 - 5 years relevant experience in Pharmaceutical Microbiology/Virology.
  • Project management skills.
  • Knowledge of regulatory and quality guidelines (GMP).
  • Able to work in multidisciplinary teams.
  • Excellent analytical and technical skills with strong support focus.
  • Demonstrated initiative, and innovative process-oriented thinking within a team environment.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Required Skills:
  • Data Analytics
  • Driving Continuous Improvement
  • Manufacturing Quality Control
  • Method Validation
  • Method Verification
  • Process Optimization
  • Technical Transfer

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): Yes

Job Posting End Date: 09/6/2026

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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