Find analytical validation Jobs in dublin, d

Senior Associate - QC Technical Services
Amgen —Dún Laoghaire, County Dublin
- €52,756.95–€71,377.05 a year
- Bachelor's degree
11d
EHR Laboratory Build Team Member
UPMC —Dublin, County Dublin
- Oracle
- ERP systems
- Clinic
- Annual leave
Packaging Manager
IRISH DISTILLERS LTD —DUBLIN 22, County Dublin
- Full-time
- Hybrid work
- Manufacturing
- Leadership
- Communication skills
- Annual leave
Quick apply
Supervisor, Laboratory Quality Control
AbbVie —Dublin, County Dublin
- Full-time
- Microsoft Office
- Supervising experience
- Bachelor's degree
Operational Security Analyst (IT & Payment Systems)
Indra Group UK & Ireland —Dublin, County Dublin
- Full-time
- Hybrid work
- Computer Science
- AWS
- Analysis skills
Quick apply
Business Support Specialist
AllPhar Services Limited —DUBLIN 24, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Analysis skills
Quick apply
Consultant - National Counter Trafficking Capacity Development
International Organization for Migration —Dublin, County Dublin
- Part-time
- System design
- English
- Bachelor's degree
12d
Data Quality & Governance Manager
Kingspan Data Solutions —Dublin, County Dublin
- Full-time
Quick apply
Data Custodian (P2) (Hybrid)
Sandvik —Dublin, County Dublin
- Full-time
- Hybrid work
- Bachelor's degree
- Communication skills
- Annual leave
- Gym membership
10d
Bioprocess Operator @ VLE Therapeutics
APC Ltd —Dublin, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- English
Quick apply
13d
Bloomberg Data Management Services (BDMS) Technical Implementation Specialist
Bloomberg —Dublin, County Dublin
- SQL
- Analysis skills
- Presentation skills
Revenue Analyst
LearnUpon —Dublin, County Dublin
- Sales
- Salesforce
- Analysis skills
- Annual leave
Product Owner - AI Team
MyComplianceOffice —Dublin, County Dublin
- Computer Science
- DevOps
- Master's degree
Reporting Engineer
AECOM —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Compliance and Operations Risk Test Lead
JPMorganChase —DUBLIN 2, County Dublin
- Full-time
- Project management
3d
Fullstack Developer - Python
Citco —Dublin, County Dublin
- Full-time
- Computer Science
- Master's degree
- AWS
Consultant - National Counter Trafficking Capacity Development
Iom Usrap Dc —Dublin, County Dublin
- Part-time
- System design
- English
- Bachelor's degree
12d
Operations Engineer - SVP
Citi —Dublin, County Dublin
- €109,920 a year
- Full-time
- Hybrid work
- Computer Science
- Finance
- Master's degree
Business Analyst (12 month FTC)
Arthur Cox —DUBLIN 2, County Dublin
- Full-time
- Hybrid work
- Computer Science
- English
- Analysis skills
- Annual leave
Quick apply
9d
Analyst, Restructuring
Kroll —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
11d

I want to receive the latest job alerts for analytical validation in dublin, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

analytical validation jobs near dublin, d

Quality Control Supervisor jobs in Dublin, County Dublin

Governance Manager jobs in Dublin, County Dublin

Revenue Analyst jobs in Dublin, County Dublin

Full Stack Developer jobs in Dublin, County Dublin

Security Analyst jobs in Dublin, County Dublin

Engineer jobs in Dublin, County Dublin

Senior Vice President jobs in Dublin, County Dublin

Community Employment Supervisor jobs in Cork, County Cork

Quality Coordinator jobs in Dublin, County Dublin

Mechanical Supervisor jobs in Dublin, County Dublin

Quality Control Supervisor jobs in Athenry, County Galway

Quality Control Supervisor jobs in Cork, County Cork

Banking Compliance jobs in Dublin, County Dublin

Compliance Officer jobs in Dublin, County Dublin

Compliance Officer jobs in Citywest, County Dublin

Compliance Officer jobs in County Donegal

Compliance Manager jobs in Dublin, County Dublin

Business Analyst jobs in Galway, County Galway

Business Analyst jobs in Sandyford, County Dublin

Legal Analyst jobs in Dublin, County Dublin

Senior Associate - QC Technical Services

Amgen -
Dún Laoghaire, County Dublin

Apply Now

Job details

€52,756.95–€71,377.05 a year
11 days ago

Qualifications

Maximo
CMMS
Bachelor's degree

Full job description

Ireland - Dun Laoghaire

JOB ID: R-245699 LOCATION: Ireland - Dun Laoghaire WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jun. 01, 2026 CATEGORY: Quality SALARY RANGE: 52,756.95 EUR - 71,377.05 EUR

Level 4 - Job Description - Amgen Dun Laoghaire - Dublin

System Owner – F&E Senior Associate – QC Equipment Support

Overview:

Supporting the technical services team, the Senior Associate is responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen Dun Laoghaire. Responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerized Maintenance Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems. The Senior Associate will act as system owner in the technical services team and will contribute to team training and mentoring.

Key Responsibilities

Supporting the Quality Control Laboratories, the System Owner is responsible for the complete life cycle of QC equipment. Responsibilities include

Equipment Lifecyle management

Select and procure laboratory equipment in accordance with Amgen requirements.
Owns and project manages change controls and adhere to Change Control metrics.
Planning, executing and documenting the qualification of new laboratory equipment in a cGxP regulated environment.
Developing and maintaining an equipment qualification project plan, requirements, qualification protocols and summary reports as part of the commissioning of new laboratory equipment.
Generation and resolution of protocol deviations as required.
Writing/contributing to equipment operating procedures and manuals.
Designing and conducting training for QC staff, and other department staff as applicable.
Developing and maintaining Data Integrity Assessments for QC laboratory systems
Conduct periodic reviews of instrument validation as part of validation life cycle.
Manage laboratory equipment replacement through Lifecycle management programmes.
Support Safety related investigations relating to laboratory equipment.

Equipment Maintanence.

Develop and own maintanence and calibration programmes for QC laboratory equipment.
Perform assessment / review of pharmacopeia updates for impacts to maintenance programmes.
Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
Coordination of equipment repairs and maintenance with vendors/contractors and also carrying out equipment maintenance as required to minimize level of down-time for laboratory equipment, and disruption to laboratory activities.
Lead programmes to improve equipment performance and reliability.
Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
Serving as the point of contact with laboratory equipment vendors and engineers.
Reviewing & filing of QC calibration & maintenance documentation.
Coordinating the audit of new vendors with Amgen Global.
Supporting deviations & investigations relating to equipment.

Quality

Recognised as QC Equipment System Owner & Business Owner.
Defend Amgen’s Laboratory systems validation, maintanence and data integrity philosophy in an Audit situation.
Contribute to a culture of CI (continuous improvement)
Participation in technical project teams as a subject matter expert on instrument validation regulations and procedures.
Participate in technical project teams to support Global/ Enterprise System Lifecycle management.
Support laboratory investigations and deviations.
Any other tasks/projects assigned as per manager’s request.

Knowledge and Experience:

Bachelor’s degree in a Science related field is required.
Minimum of 5 + years of laboratory experience in a cGXP laboratory environment including exposure to analytical instrument validation.
Detailed knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
Understanding of current regulatory requirements for cGXP laboratory equipment validation and electronic record integrity.
Demonstrated success in managing an equipment qualification or maintenance program advantageous.
Key Amgen Values: Ensure Quality, Team Work, Be Science Based, Collaborate, Communicate, Be Accountable

Apply Now

Refine Your Search

analytical validation jobs in dublin, d

Senior Associate - QC Technical Services

EHR Laboratory Build Team Member

Packaging Manager

Supervisor, Laboratory Quality Control

Operational Security Analyst (IT & Payment Systems)

Business Support Specialist

Consultant - National Counter Trafficking Capacity Development

Data Quality & Governance Manager

Data Custodian (P2) (Hybrid)

Bioprocess Operator @ VLE Therapeutics

Bloomberg Data Management Services (BDMS) Technical Implementation Specialist

Revenue Analyst

Product Owner - AI Team

Reporting Engineer

Compliance and Operations Risk Test Lead

Fullstack Developer - Python

Consultant - National Counter Trafficking Capacity Development

Operations Engineer - SVP

Business Analyst (12 month FTC)

Analyst, Restructuring

I want to receive the latest job alerts for analytical validation in dublin, d

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected