CQV Engineer
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| Job Type | Contractor |
| Area | Roscommon, IrelandWestmeath, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1001996 |
| Job Views | 85 |
- Description
- We are seeking applications for an experienced Validation Engineer for our client, who are a leading biopharmaceutical company based in Athlone. The successful candidate will prepare the necessary documentation and monitor progress for technical projects across the organization. And will be a contributor in 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:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Drafting, reviewing and approving Validation documentation.
Coordinating documentation for Project and Sustaining operations
Executing temperature mapping studies
Participating in validation risk assessments
Supporting sustaining and project Validation activities across Bulk Drug Substance, Packaging and Laboratory areas.
Inputting into the core aspects of Operations, Qualification and Validation SOP's.
Maintaining hardcopy records in Document control archive, including reconciliation of Document tracker.
Developing library of softcopy versions of all Validation test documentation
Supporting closeout of TrackWise actions for Validation team
Raising, supporting and resolving validation deviations as they occur.
Coordinating a Validation dashboard update for site management / leadership
Ensuring requalification and periodic review activities are completed in a timely manner
Providing support in areas of commissioning and qualification of mechanical, process, electrical, automation equipment and systems and performance test protocols.
Presenting on project updates as required
Encouraging a high safety culture and performance within the validation teams.
What you need to apply:
Technical Degree in Engineering/Life Sciences
6 years+ relevant experience working in a validation role in the Pharmaceutical / Biotechnology industry.
Skilled at upstream / downstream drug substance processes would be an advantage.
Proven ability to work effectively with various departments and resolve issues in structured manner.
Strong technical capabilities, communication skills, teamwork abilities and initiative.
Good knowledge of regulatory requirements and current Health and Safety Regulations legislation.
Proven ability to work well as part of a team & on own