Job Details: Automation Systems Validation (ASV) Engineer


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Automation Systems Validation (ASV) Engineer
The Role

We are actively looking for an Automation Systems Validation (ASV)
Engineer to join a growing team on site. The Automation Validation
Engineer will be responsible for the Development of Validation Plans
for our client&#**Apply on the website**;s biotech facility in Dublin
West.

Duties

? Provide technical support in validation to meet objectives of
quality

? Development of Validation Plans, Installation Qualifications
(IQs), Operational Qualifications (OQs), Process Qualifications (PQs),
and System Summaries

? Pre-approval of Automation Change Packs to ensure the correct
testing is included and the correct document updates are being made.

? Post change review of Automation Change Packs to ensure testing
was performed as agreed and any test faults correctly documented and
closed.

? Perform periodic reviews on Automated Control systems to ensure
the validated state of the system is maintained. ASV are also
responsible for generating the annual periodic review plan for
Automation.

? Perform biennial reviews of Automation Procedures and document
updates as needed following the reviews. (Periodic reviews and
biennial reviews must be performed to meet agreed timings.)

? Review/approval of test documents for new/modified code.

? Ensure compliance with site procedures and Regulatory Requirements

? Responsible for assessing the validation of Automation Systems as
part of Annual Product Quality Reviews

Requirements

? A Bachelor&#**Apply on the website**;s degree in Computer Science,
Computer Engineering, Computer Information Systems, or a related field
(Technology Management; Chemical Engineering)

? Minimum of 3 years relevant experience of working within the
Pharmaceutical sector

? Must have at least 2 years&#**Apply on the website**; experience
implementing and supporting automation systems for manufacturing
organizations in the biotechnology or pharmaceutical industries.

? Must have demonstrated experience in the delivery and management
of Automation systems in addition to a working knowledge of GAMP
software development lifecycle, ANSI/ISA-S**Apply on the website**
industry standards

Zenith Technologies, now a Cognizant Company is a world leader in
delivering digital transformation solutions to Life Sciences. Through
our knowledge and expertise in Automation, MES & Digital, we deliver
stable manufacturing systems that are optimised to improve operational
efficiencies, whilst maintaining compliance. Our specialist
engineering teams have the aptitude to deliver and support Pharma 4.0
architectures and solutions covering all IT, OT and IoT applications,
infrastructures and services. Operating across 5 continents and with
over **Apply on the website** skilled employees, Zenith partners with
the leading Life Sciences companies globally to provide performance
improvements, reduced costs and improve time to market The Role

We are actively looking for an Automation Systems Validation (ASV)
Engineer to join a growing team on site. The Automation Validation
Engineer will be responsible for the Development of Validation Plans
for our client&#**Apply on the website**;s biotech facility in Dublin
West.

Duties

? Provide technical support in validation to meet objectives of
quality

? Development of Validation Plans, Installation Qualifications
(IQs), Operational Qualifications (OQs), Process Qualifications (PQs),
and System Summaries

? Pre-approval of Automation Change Packs to ensure the correct
testing is included and the correct document updates are being made.

? Post change review of Automation Change Packs to ensure testing
was performed as agreed and any test faults correctly documented and
closed.

? Perform periodic reviews on Automated Control systems to ensure
the validated state of the system is maintained. ASV are also
responsible for generating the annual periodic review plan for
Automation.

? Perform biennial reviews of Automation Procedures and document
updates as needed following the reviews. (Periodic reviews and
biennial reviews must be performed to meet agreed timings.)

? Review/approval of test documents for new/modified code.

? Ensure compliance with site procedures and Regulatory Requirements

? Responsible for assessing the validation of Automation Systems as
part of Annual Product Quality Reviews

Requirements

? A Bachelor&#**Apply on the website**;s degree in Computer Science,
Computer Engineering, Computer Information Systems, or a related field
(Technology Management; Chemical Engineering)

? Minimum of 3 years relevant experience of working within the
Pharmaceutical sector

? Must have at least 2 years&#**Apply on the website**; experience
implementing and supporting automation systems for manufacturing
organizations in the biotechnology or pharmaceutical industries.

? Must have demonstrated experience in the delivery and management
of Automation systems in addition to a working knowledge of GAMP
software development lifecycle, ANSI/ISA-S**Apply on the website**
industry standards

Zenith Technologies, now a Cognizant Company is a world leader in
delivering digital transformation solutions to Life Sciences. Through
our knowledge and expertise in Automation, MES & Digital, we deliver
stable manufacturing systems that are optimised to improve operational
efficiencies, whilst maintaining compliance. Our specialist
engineering teams have the aptitude to deliver and support Pharma 4.0
architectures and solutions covering all IT, OT and IoT applications,
infrastructures and services. Operating across 5 continents and with
over **Apply on the website** skilled employees, Zenith partners with
the leading Life Sciences companies globally to provide performance
improvements, reduced costs and improve time to market

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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