Job Type: Contract
Job ID: JO-1812-12182
Consultant: Karen McHugh
Are you a CSV Engineer with 3+ years experience in; cGMP Regulated Environment / computer system / validation lifecycle / working knowledge of GAMP software development lifecycle?
If you have the relevant experience, send your CV to email@example.com or call +35317978720 for a confidential chat.
CSV Engineer- Validation - Amgen - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
Review and Approve validation protocols and assessments from a quality system documentation perspective.
Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues.
Participate and communicate as required in project activities.
Develop procedures to manage computerised systems where required
Develop and present project plans to project management senior staff
Bachelor of Science/Engineering degree or equivalent.
Candidates must have at least 3 years experience in: cGMP Regulated Environment | computer system validation lifecycle | working knowledge of GAMP software development lifecycle
Knowledge of cGMP’s and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications skills
Understanding of the computer system validation lifecycle
Candidates must have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.
The successful candidate will have a least 3 years experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries.
Basic hourly rate of €40 - 55 per hour
Minimum contract duration: 12 months
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail firstname.lastname@example.org or phone +353-1-7978720
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