Senior Process Validation Engineer - Biotech - Dun Laoghaire - Dublin

Location: Ireland

EUR 55 - 65 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19254

Consultant: Karen McHugh

Are you a Validation engineer with 5+ years BioPharma experience? 

Have you managed External Manufacturing sites ?

If you have the relevant experience, please forward your CV to for review or call 353 1 7978720 to discuss in confidence.

Senior Process Validation Engineer - Biotech - Dun Laoghaire - Dublin


Our Client is Amgen and the role will be based in their Dun Laoghaire plant. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

Job Description

Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.

Be an integral quality member of the cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc. 

Translates Amgen requirements into the language of the CMO-can make a risk-based decision 

Validation document author/approver 

Ensure validated parameters are correctly incorporated in Master Batch Records 

Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship 

Validation change control assessment 

Perform Person in Plant activities as required 

Author applicable MA filing sections 

Write/review RTQs 

Prepare inspection playbooks 

Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas 

Drive Operational Excellence and Champion Change 

Determine validation strategy and outcome of validation activities 

Decision to approve or reject validation documentation 

Provide Validation position on related topics and strategy for the site 


5 + years (ideally 8 years +) biotech or pharmaceutical industry experience 

Significant Validation experience at Aseptic Manufacturing or API facilities 

Able to facilitate and influence senior stakeholders and partners 

Able to successfully manage workload and timelines 

Familiarity with basic project management tools 

Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn't first language) 

Strong project management, problem-solving, and analytical skills 

Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution 

Ability to operate in a matrixed or team environment with site, functional, and executive leadership 

Experience driving decision making 

Additional European Languages - desirable not essential


Hourly Rate €60 - €65 per hour

Minimum contract duration: 12 months

Potential to work from home


Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail or phone +353-1-7978720


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