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Validation Engineer CIP
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Client, Engineer
Projektbeschreibung
Role - Validation Engineer - CIP
Type - initially 12 month contract
Location - Co. Limerick
Summary
One of our key clients, a global leader within pharmaceuticals, is looking for a highly experienced Validation Lead for CIP. Responsible for the day-to-day authoring and execution of Validation activities and working with the broader QA Validation and Automation Teams to ensure validation deliverables are completed per schedule.
Key Responsibilities:
Completion of Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility.
Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, Cleaning Validation protocols; drive approval of same.
Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
Interface with the client on Commissioning and Process Sciences teams.
Support CIP validation programs as necessary.
Support the client Management in Project delivery.
Key Requirements:
Strong background within the Biopharmaceutical environment experience
Experience in Document Preparation and Execution
Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
Good technical knowledge of equipment and the concepts of BioTech manufacturing
Type - initially 12 month contract
Location - Co. Limerick
Summary
One of our key clients, a global leader within pharmaceuticals, is looking for a highly experienced Validation Lead for CIP. Responsible for the day-to-day authoring and execution of Validation activities and working with the broader QA Validation and Automation Teams to ensure validation deliverables are completed per schedule.
Key Responsibilities:
Completion of Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility.
Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, Cleaning Validation protocols; drive approval of same.
Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
Interface with the client on Commissioning and Process Sciences teams.
Support CIP validation programs as necessary.
Support the client Management in Project delivery.
Key Requirements:
Strong background within the Biopharmaceutical environment experience
Experience in Document Preparation and Execution
Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
Good technical knowledge of equipment and the concepts of BioTech manufacturing
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik