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Commissioning Manager
Eingestellt von Experis IT
Gesuchte Skills: Engineering, Client
Projektbeschreibung
COMMISSIONING MANAGER
Our client, a leading biotech company, is looking for an experienced Commissioning Manager to support site expansion. This role will focus on Commissioning and Qualification of bio pharmaceutical manufacturing equipment and processes.
JOB REQUIREMENTS/ACCOUNTABILITIES:
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
- Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)
- Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
- Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
- Promote cGMP and regulatory compliance into assigned projects
- Review and modification of standard operating procedures (SOPs) for various equipment
Document, monitor, and report on project deliverables - Manage project documentation such as protocols, reports, calibration certificates, and process trends.
- Acting as a 'Commissioning System Owner' for a given system
- Facilitating and expediting construction handover/mechanical completion
- Liaising with/co-ordinating vendors, contractors and the site team to complete all scope of works
- Ensuring the installation and operation of your equipment/system meets project and client requirements
SKILLS & EXPERIENCE
- BS or MS in Engineering or related discipline
- 5+ years in validation, quality systems, operations, engineering or any combination there of
- Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge
- Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards
- Ability to relate with people at all levels within an organization, including diverse cultures
IF YOU ARE INTERESTED IN THIS ROLE PLEASE CONTACT AINE FANNING OR EMAIL
Our client, a leading biotech company, is looking for an experienced Commissioning Manager to support site expansion. This role will focus on Commissioning and Qualification of bio pharmaceutical manufacturing equipment and processes.
JOB REQUIREMENTS/ACCOUNTABILITIES:
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
- Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)
- Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
- Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
- Promote cGMP and regulatory compliance into assigned projects
- Review and modification of standard operating procedures (SOPs) for various equipment
Document, monitor, and report on project deliverables - Manage project documentation such as protocols, reports, calibration certificates, and process trends.
- Acting as a 'Commissioning System Owner' for a given system
- Facilitating and expediting construction handover/mechanical completion
- Liaising with/co-ordinating vendors, contractors and the site team to complete all scope of works
- Ensuring the installation and operation of your equipment/system meets project and client requirements
SKILLS & EXPERIENCE
- BS or MS in Engineering or related discipline
- 5+ years in validation, quality systems, operations, engineering or any combination there of
- Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge
- Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards
- Ability to relate with people at all levels within an organization, including diverse cultures
IF YOU ARE INTERESTED IN THIS ROLE PLEASE CONTACT AINE FANNING OR EMAIL
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik