Title: Validation Engineer
Location: Sligo, Ireland
Type: 6-Month Contract
Salary: DOE
Ref: DES-1239
Job Overview
An experienced Validation Engineer is required to support validation and qualification activities within a regulated pharmaceutical manufacturing environment. The successful candidate will play a key role in validation execution across equipment, utilities, processes, and systems while ensuring full compliance with cGMP and regulatory requirements.
Responsibilities
- Actively participate in site validation programmes and general Quality Assurance activities.
- Coordinate, direct, and execute validation and qualification activities for equipment, utilities, processes, and software in line with cGMP and GAMP standards.
- Generate, maintain, and execute Project Validation Plans and validation schedules.
- Prepare validation protocols and final reports to cGMP standards.
- Provide QA support for validation investigations and implementation of corrective actions.
- Supervise vendors during execution of validation activities.
- Execute Autoclave, Parts Washer, Lyophiliser, CIP, SIP, VHP, and Temperature Mapping validation activities to support initial validation and revalidation requirements.
- Create, review, and approve validation and qualification documentation.
- Manage validation deviations, exception events, and change controls.
- Ensure all validation activities are documented in compliance with cGMP requirements.
- Support cross-training initiatives and onboarding of new team members.
- Participate in continuous improvement programmes to enhance manufacturing, quality, safety, and training systems.
- Coordinate activities to maximise team effectiveness and project delivery.
- Communicate effectively with peers and management regarding project activities, concerns, and escalations where required.
Requirements
- Relevant degree qualification in Engineering, Science, or related discipline.
- Minimum 5 years’ experience within pharmaceutical or regulated manufacturing environments.
- Strong hands-on Autoclave validation execution experience.
- Experience with aseptic processing validation, including Media Fills and VHP validation execution.
- HVAC validation experience is essential.
- Strong understanding of cGMP, FDA, and regulatory compliance requirements.
- Excellent documentation, communication, and organisational skills.
*Only candidates with a valid work visa for Ireland or an EU passport will be considered.
For more information, please contact Corné on 0949316002 or email [email protected]
IND001
Education:
Experience:
- Pharmaceutical Manufacturing : 5 years (required)
Work authorisation:
Work Location: In person
