A leading bio-pharmaceutical organisation who have established a new state-of-the-art facility in north Leinster are looking for an experienced Validation Engineer with specialisation in either process or cleaning validation. This is a new site within the global network to niche customer requirements and will supply product into global markets. As this is the company's first site of this nature the engineering department will work closely with the global group to complete detailed design and all other processes and protocols as required. The company currently employs over 3,000 staff globally across their biologics business operations.
- To be responsible for DQ, IQ, OQ, PQ, CV and PV following validation plans and complying with cGMP.
- To draft validation protocols and finalise reports.
- To maintain site validation procedures and relevant SOPs for shipping, cleaning, and process validation.
- To provide information on relevant regulations and internal validation policy with regards to equipment/instrument, facility, utility, and process validations.
- To verify that validation studies once complete have been adequately recorded, documented, and carried out, in accordance with the approved validation plan and protocols.
- To provide assistance and ensure the preparation of validation protocols, design specifications and associated documentation for equipment, systems, and processes.
- To participate in project teams and assist in determining project schedules and the relevance of appropriate levels of validation.
- At least 5+ years' experience in a GMP environment as a Validation Engineer.
- Experience with validation for sterile environments, equipment/instrument, facility, and utility.
- Familiar with Shipping Validation, Cleaning Validation and Process Validation.
- Works with the team and other departments across the plant to ensure project adherence.
- Excellent English oral and written communication skills, leadership ability and ethical judgment.
- Ability to work collaboratively within a team and with other departments.
- Ability to work effectively with minimal supervision.
To learn more, apply online or contact Pádraig on +353 87 428 0873 or please submit an updated CV.