Job Type: Contract
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 firstname.lastname@example.org 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.
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
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 email@example.com or phone +353-1-7978720
© 2018 JobContax All Rights Reserved