Job Details: Abbvie Compliance Engineer/Data Integrity


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Jervis Street
Dublin 1
jobsireland.ie
Abbvie Compliance Engineer/Data Integrity
Position: #Abbvie Compliance Engineer (Data Integrity)

DATA INTEGRITY ENGINEER

WANT TO JOIN AN AWARD WINNING TEAM?

READY TO MAKE A WORLDWIDE IMPACT?

WELCOME TO ABBVIE!

WE ARE NOW RECRUITING A DATA INTEGRITY ENGINEER TO JOIN OUR DIVERSE
UNIT DOSE MANUFACTURING TEAM IN WESTPORT, MAYO. AS OUR DATA INTEGRITY
ENGINEER YOU WILL TAKE OWNERSHIP FOR A COMBINATION, COMPUTER
ENGINEERING, SYSTEMS ENGINEERING AND CONTROL ENGINEERING. THE DI
ENGINEER WORKS CLOSELY WITH OPERATIONS, QA, ENGINEERING AND
MAINTENANCE TO DRIVE DATA INTEGRITY REQUIREMENTS FOR THE BUSINESS
UNIT.

SO, WHAT DO YOU NEED TO DO THIS ROLE?

KEY RESPONSIBILITIES
You will manage and drive data integrity requirements for the Business
Unit. Lead and provide feedback to project owners on the status data
integrity projects in the Business Unit. Support the Business Unit
during audits from a data integrity perspective. Lead the generation
and routing of data integrity and system-based documents through the
Quality Assurance process. Complete data Integrity reviews and
subsequent remediation activities of business unit systems and
processes. Generate data process maps to describe the data flows
throughout the systems and to identify critical data control
points/transactions. Identify data integrity gaps and propose
solutions. We believe in collaboration so in this role, you will
partner with remediation activities including any potential validation
activities to address identified process and/or equipment data
integrity gaps. Lead and/or assist the development of critical alarm
matrix for systems which will lead into procedural controls. Develop
training modules to continue the upskill and awareness of data
integrity across the business unit. Develop matrix of the systems
access levels across users, set ups, administrators and engineers. You
will comply with the data integrity of new installs and upgrades to
meet Annex **Apply on the website** and **Apply on the website**CFR
Part **Apply on the website** Updating of the current system risk
assessments and risk mitigation plans. Completion of risk assessments
for new installs. Support personnel in effective audit trial reviews.

Qualifications

EDUCATION
YOU WILL HAVE A RELEVANT THIRD LEVEL QUALIFICATION IN AN ENGINEERING,
SCIENCE OR TECHNICAL DISCIPLINE (DEGREE LEVEL PREFERABLE)

TECHNICAL SKILLS AND EXPERIENCE
Detailed knowledge of regulatory requirements in a pharmaceutical GxP
environment. At least 3 years? experience in a highly automated
manufacturing environment Experience: SAP, Coral, Quality software
systems, working with Microsoft Office (Word, Excel, PowerPoint etc.).
Experience of working on a team, including strong organisational and
time management skills. Ability to learn new and different
technologies. Solution focused, with in-depth technical knowledge of
both procedural controls and system controls for managing data
Integrity. Motivated and passionate about production systems.
Excellent documentation, organisational and prioritisation skills.
Ability to effectively communicate plans, proposals, and actions at
management levels. Total commitment to quality and a high standard of
work always.

Job Type

Standard

Schedule

Full-time

Equal Employment Opportunity

At Allergan, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients. As
an equal opportunity employer we do not discriminate on the basis of
race, color, religion, national origin, age, sex (including
pregnancy), physical or mental disability, medical condition, genetic
information gender identity or expression, sexual orientation, marital
status, protected veteran status, or any other legally protected
characteristic.

Position: #Abbvie Compliance Engineer (Data Integrity)

DATA INTEGRITY ENGINEER

WANT TO JOIN AN AWARD WINNING TEAM?

READY TO MAKE A WORLDWIDE IMPACT?

WELCOME TO ABBVIE!

WE ARE NOW RECRUITING A DATA INTEGRITY ENGINEER TO JOIN OUR DIVERSE
UNIT DOSE MANUFACTURING TEAM IN WESTPORT, MAYO. AS OUR DATA INTEGRITY
ENGINEER YOU WILL TAKE OWNERSHIP FOR A COMBINATION, COMPUTER
ENGINEERING, SYSTEMS ENGINEERING AND CONTROL ENGINEERING. THE DI
ENGINEER WORKS CLOSELY WITH OPERATIONS, QA, ENGINEERING AND
MAINTENANCE TO DRIVE DATA INTEGRITY REQUIREMENTS FOR THE BUSINESS
UNIT.

SO, WHAT DO YOU NEED TO DO THIS ROLE?

KEY RESPONSIBILITIES
You will manage and drive data integrity requirements for the Business
Unit. Lead and provide feedback to project owners on the status data
integrity projects in the Business Unit. Support the Business Unit
during audits from a data integrity perspective. Lead the generation
and routing of data integrity and system-based documents through the
Quality Assurance process. Complete data Integrity reviews and
subsequent remediation activities of business unit systems and
processes. Generate data process maps to describe the data flows
throughout the systems and to identify critical data control
points/transactions. Identify data integrity gaps and propose
solutions. We believe in collaboration so in this role, you will
partner with remediation activities including any potential validation
activities to address identified process and/or equipment data
integrity gaps. Lead and/or assist the development of critical alarm
matrix for systems which will lead into procedural controls. Develop
training modules to continue the upskill and awareness of data
integrity across the business unit. Develop matrix of the systems
access levels across users, set ups, administrators and engineers. You
will comply with the data integrity of new installs and upgrades to
meet Annex **Apply on the website** and **Apply on the website**CFR
Part **Apply on the website** Updating of the current system risk
assessments and risk mitigation plans. Completion of risk assessments
for new installs. Support personnel in effective audit trial reviews.

Qualifications

EDUCATION
YOU WILL HAVE A RELEVANT THIRD LEVEL QUALIFICATION IN AN ENGINEERING,
SCIENCE OR TECHNICAL DISCIPLINE (DEGREE LEVEL PREFERABLE)

TECHNICAL SKILLS AND EXPERIENCE
Detailed knowledge of regulatory requirements in a pharmaceutical GxP
environment. At least 3 years? experience in a highly automated
manufacturing environment Experience: SAP, Coral, Quality software
systems, working with Microsoft Office (Word, Excel, PowerPoint etc.).
Experience of working on a team, including strong organisational and
time management skills. Ability to learn new and different
technologies. Solution focused, with in-depth technical knowledge of
both procedural controls and system controls for managing data
Integrity. Motivated and passionate about production systems.
Excellent documentation, organisational and prioritisation skills.
Ability to effectively communicate plans, proposals, and actions at
management levels. Total commitment to quality and a high standard of
work always.

Job Type

Standard

Schedule

Full-time

Equal Employment Opportunity

At Allergan, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients. As
an equal opportunity employer we do not discriminate on the basis of
race, color, religion, national origin, age, sex (including
pregnancy), physical or mental disability, medical condition, genetic
information gender identity or expression, sexual orientation, marital
status, protected veteran status, or any other legally protected
characteristic.



We need : English (Good)

Type: Permanent
Payment:
Category: Others

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