We are seeking a motivated and detail-oriented Quality Engineer to join our team in Cork. This site-based role is located within a large GMP-regulated manufacturing facility and is ideally suited to a quality professional with around 2 years of experience supporting validation activities, protocol execution, and quality documentation within the pharmaceutical, biotechnology, medical device, or broader life sciences sector
The successful candidate will play a key role in ensuring compliance with quality and regulatory requirements, supporting validation programmes, and driving continuous improvement initiatives across manufacturing and quality operation
Key Responsibilities
- Support the development, execution, review, and approval of validation and qualification documentation, including IQ, OQ, PQ, and associated protocols and reports.
- Ensure validation activities are completed in accordance with GMP requirements, site procedures, and regulatory expectations.
- Assist with the management and maintenance of quality documentation, including change controls, deviations, CAPAs, and risk assessments.
- Participate in root cause investigations and support the implementation of effective corrective and preventive actions.
- Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, Quality Assurance, and Regulatory Affairs to maintain compliance and product quality.
- Support equipment and process validation activities as required.
- Assist with internal and external audits and ensure timely resolution of audit observations.
- Contribute to quality metrics, continuous improvement projects, and operational excellence initiatives.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline.
- Minimum of 2 years' experience in a Quality, Validation, or Compliance role within a GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences environment.
- Practical experience working with validation protocols, qualification documentation, and GMP documentation practices.
- Strong understanding of GMP requirements and quality systems.
- Experience supporting investigations, deviations, CAPAs, and change control processes.
- Excellent attention to detail, documentation, communication, and organisational skills.
- Ability to work effectively within a cross-functional team environment.
Desirable Experience
- Experience supporting equipment or process validation activities.
- Familiarity with risk management methodologies and validation lifecycle principles.
- Knowledge of electronic quality management systems (eQMS) and document management systems.
- Experience participating in audits and regulatory inspections.
Benefits:
Work Location: In person
