Fully Irish‑owned, the firm emerged from its founders’ deep expertise within the pharma and medical‑device sectors.
It sources both contract/interim and permanent specialist talent across life‑science and energy industries in Ireland.
Typical clients span pharmaceuticals, biopharma, medical devices, CROs, semiconductors, energy, and data-centre projects.
They uniquely combine technical screening by industry veterans with a hands‑on approach to match candidates to company culture and project needs.
Despite a compact size, they’ve placed high‑level talent in complex environments—handling everything from FAT/SAT validation to EHS coordination and CQV roles.
Headquartered in Castlebar, Co. Mayo, they’ve built a reputation as agile trusted partners who can quickly deploy niche skill sets when projects demand.
About the client
About the client
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Role
Description
em analysis
change control
risk management
sterility investigation
aseptic training
regulatory audits
Partner with Quality SMEs, Engineering SMEs, Aseptic MQA, and Aseptic Mentors to ensure manufacturing shifts have the support needed to complete product batches safely, compliantly, and in an aseptic manner.
Support regulatory audits as an Aseptic/Sterility Assurance SME.
Provide key input for the Manufacturing Batch Record.
Own analysis and trending of Environmental Monitoring (EM) data, including responsibility for the EM Visualization Tool. Develop and execute action plans to address EM trends.
Ensure all procedures and changes follow site Change Control procedures.
Ensure Operations procedures comply with Safety and Environmental Regulations, Aseptic and GMP regulatory requirements, and network best practices.
Lead and support investigations into sterility, media fill, EM excursions, and EMPQ issues, contributing to root cause and CAPA development.
a) Assessing and applying new Aseptic Manufacturing regulations
Drive continuous improvement of aseptic procedures by:
Support training of Operations personnel in aseptic technique and aseptic processing procedures.
Provide key input into Site LRP for Aseptic Manufacturing.
Provide key input into the Site Contamination Control Strategy.
Provide key input into the site APS strategy.
Act as a site Subject Matter Expert (SME) for Aseptic Manufacturing.
Provide key input into cleanroom/equipment/utility design, qualification, re-qualification, and preventative maintenance strategies.
Routinely observe aseptic technique and behaviour of shift teams, giving feedback during critical activities such as Cleaning, Sanitization, Aseptic Set-up, EM plate handling, and Interventions.
Participate in routine leadership GEMBAs of manufacturing and testing areas.
b) Developing and implementing best practices
Provide key input into setting up the manufacturing process.
Drive a high-performance culture through communication, colleague engagement, and a speak-up culture.
Ensure effective use of Risk Management tools to support aseptic performance and sterility assurance, including pFMEA and What If/HAZOP assessments.
Requirements
gmp knowledge
science degree
aseptic experience
risk management
capa
eu visa
Only candidates with a valid work visa for Ireland or an EU passport will be considered.
Strong knowledge of EU GMP Annex 1, FDA 21 CFR Part 610, 210, 211, and FDA guidance “Sterile Drug Products Produced by Aseptic Processing - CGMP.”
Third-level degree in Science, Quality, or Engineering.
5+ years in a GMP environment, with 3+ years supporting Aseptic Manufacturing (non-negotiable).
SME-level experience with risk management tools including contamination control strategy, pFMEA, HAZOP, and What If.
Experience tracking and trending environmental monitoring data as a microbial SME.
Experience in investigations related to sterility, media fill, environmental monitoring excursions, and EMPQ, including root cause and CAPA.