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CSV/Automation Engineer- Biopharma
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineering, Support, Engineer
Projektbeschreibung
POSITION SUMMARY
Our client is initiating a project to construct a bio-pharma facility at its site in Ireland. The facility is to consist of upstream and downstream processing trains with all required utilities.
This position will be based at the client's facility in Dublin. The computer systems (automation) validation engineer will be part of the control systems design and implementation team reporting to the Senior Manager of Manufacturing Systems. The team will be responsible for all automation systems that are to be introduced as part of the project.
This position will require travel to system integrator sites to participate in design reviews, factory acceptance tests and project meetings
PRINCIPAL RESPONSIBILITIES
- Ensure that all automation systems introduced as part of the project are validated to requirements and recognised international standards (FDA. EU)
- Develop validation plans, installation qualifications, operational qualifications, performance qualifications and summary reports.
- Develop a validation plan to successfully deliver fully qualified/validated automated systems in line with the project schedule.
- Liaise with the IT validation team to ensure that all supporting IT validation deliverables are met
- Participate in cross site validation functional teams to ensure that all current site procedures are being followed
- Lead all required risk assessments for automation systems
- Develop a lean change control procedure including standardised testing
- Introduce documentation practices/systems to provide traceability of all changes
- Act as the point of contact for all computer system validation related issues.
- Liaise with engineering and external vendors regarding equipment User Requirement Specifications (URS's), Factory Acceptance Tests (Fat's) and any other associated validation issues.
- Participate as required in project activities
- Provide progress reports as required to senior management.
- Provide training, guidance and governance in the automation procedures and processes implemented across site
- Implement and own the automation change control process
- Develop standard operating procedures as required to ensure the compliance of all automation systems on site
- Develop engineering standards for all instrumentation and control systems as required to support current and future projects within the company
- Participate in FAT and SAT activities
- Lead a team of automation system validation engineers during commissioning and ramp up of the facility
- Support the preparation and creation of site change controls for the automation department.
- Prepare reports as required to support project deliverables
- If the project dictates, provide off-hours coverage (nights and weekends) as necessary for validation activities
- Participate in cross-functional teams to ensure a high level of reliability for all equipment.
- Proactively manage the life cycle of all computer systems
QUALIFICATONS
Experience in the area of computer systems validation within a GMP environment
- Must be able to work independently with a proven history of delivering validated computer systems within a large project.
- Direct experience in the validation of a DeltaV platform
- KNOWLEDGE OF THE ASTM E2500 STANDARD GUIDE FOR THE SPECIFICATION, DESIGN AND VERIFICATION OF PHARMACEUTICAL AND BIOPHARMACEUTICAL MANUFACTURING SYSTEMS AND EQUIPMENT.
- Experience delivering a risk based approach to validation of computer systems
- Experience of IT infrastructure
- A comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure site instrumentation and control systems are cGMP compliant.
- Good interpersonal skills are required, as is the ability to communicate well, both verbally and written documents.
- Proven experience in managing external contractors
EDUCATION
- Degree in Mechanical/Electrical/Computer Engineering or equivalent
- biopharmaceutical project start up experience
- Demonstrable Delta V Experience
Our client is initiating a project to construct a bio-pharma facility at its site in Ireland. The facility is to consist of upstream and downstream processing trains with all required utilities.
This position will be based at the client's facility in Dublin. The computer systems (automation) validation engineer will be part of the control systems design and implementation team reporting to the Senior Manager of Manufacturing Systems. The team will be responsible for all automation systems that are to be introduced as part of the project.
This position will require travel to system integrator sites to participate in design reviews, factory acceptance tests and project meetings
PRINCIPAL RESPONSIBILITIES
- Ensure that all automation systems introduced as part of the project are validated to requirements and recognised international standards (FDA. EU)
- Develop validation plans, installation qualifications, operational qualifications, performance qualifications and summary reports.
- Develop a validation plan to successfully deliver fully qualified/validated automated systems in line with the project schedule.
- Liaise with the IT validation team to ensure that all supporting IT validation deliverables are met
- Participate in cross site validation functional teams to ensure that all current site procedures are being followed
- Lead all required risk assessments for automation systems
- Develop a lean change control procedure including standardised testing
- Introduce documentation practices/systems to provide traceability of all changes
- Act as the point of contact for all computer system validation related issues.
- Liaise with engineering and external vendors regarding equipment User Requirement Specifications (URS's), Factory Acceptance Tests (Fat's) and any other associated validation issues.
- Participate as required in project activities
- Provide progress reports as required to senior management.
- Provide training, guidance and governance in the automation procedures and processes implemented across site
- Implement and own the automation change control process
- Develop standard operating procedures as required to ensure the compliance of all automation systems on site
- Develop engineering standards for all instrumentation and control systems as required to support current and future projects within the company
- Participate in FAT and SAT activities
- Lead a team of automation system validation engineers during commissioning and ramp up of the facility
- Support the preparation and creation of site change controls for the automation department.
- Prepare reports as required to support project deliverables
- If the project dictates, provide off-hours coverage (nights and weekends) as necessary for validation activities
- Participate in cross-functional teams to ensure a high level of reliability for all equipment.
- Proactively manage the life cycle of all computer systems
QUALIFICATONS
Experience in the area of computer systems validation within a GMP environment
- Must be able to work independently with a proven history of delivering validated computer systems within a large project.
- Direct experience in the validation of a DeltaV platform
- KNOWLEDGE OF THE ASTM E2500 STANDARD GUIDE FOR THE SPECIFICATION, DESIGN AND VERIFICATION OF PHARMACEUTICAL AND BIOPHARMACEUTICAL MANUFACTURING SYSTEMS AND EQUIPMENT.
- Experience delivering a risk based approach to validation of computer systems
- Experience of IT infrastructure
- A comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure site instrumentation and control systems are cGMP compliant.
- Good interpersonal skills are required, as is the ability to communicate well, both verbally and written documents.
- Proven experience in managing external contractors
EDUCATION
- Degree in Mechanical/Electrical/Computer Engineering or equivalent
- biopharmaceutical project start up experience
- Demonstrable Delta V Experience
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges