Packaging Validation Engineer
| Job Type | Contractor |
| Area | Dublin |
| Sector | EngineeringOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2219 |
| Job Views | 206 |
- Description
- Due to an Increase in the number of NPI’s and equipment within the Packaging area at our Clients Bulk Drug Substance manufacturing facility, we have an opportunity available for a Packaging Validation Engineer. Reporting to the Validation Lead you willprepare the necessary documentation and monitor progress for technical projects across the organization within the Packaging/Device Assembly Department. You will also be supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the bio pharma industry.
Why you should apply:- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
- Competitive rates on offer
- Draft and perform validation testing on product secondary packaging and device assembly equipment.
- Manage trials on machines or with various processes. Inspect production processes and prepare protocols and summary reports for manufacturing and packaging equipment.
- Prepare, maintain, or review validation documentation, such as engineering change controls, diagrams, reports or protocols.
- Review manufacturing processes and perform equipment and process validation studies and recommend process improvements.
- Review equipment validation periodically to determine it remains within validated state.
- Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Design Device Assembly studies to support qualification
- Review validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Execute Validation Risk Assessments to determine the level of testing required for new equipment
- Manage Computer System Validation requirements of various packaging/device assembly equipment
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Provide SME support to closing all validation Records (CAPAs/Change Controls/Deviations)
- Encourage and sustain a high safety culture and performance within the Validation teams.
- Knowledge of Combination Products Regulations
What you need to apply:- Technical Degree in Engineering/Life Sciences
- Relevant experience working in a Validation role in the pharmaceutical industry.
- Experience of packaging/device assembly equipment and associated qualification.
- Demonstrated ability to work effectively with various departments and resolve issues in structured manner.
- Strong technical capabilities, communication skills, teamwork abilities and initiative.
- Strong knowledge of regulatory requirements and current Health and Safety Regulations legislation.
- Proven ability to work well as part of a team & on own.
