Method Development & Validation Specialist
* Full-time
We have an opportunity for a Method Development & Validation Specialist to join our PSS Site in Currabinny.
Consider joining Eurofins PSS, where people are the most important element in our business. Eurofins PSS is the global leader in scientific insourcing services. PSS has been serving for over 15 years in Ireland and over 22 years globally.
For more information about Eurofins PSS, please visit our website and watch a message from our Global Head, Beth Di Paolo.
We currently have exciting opportunities to join our innovative and multi award-winning Professional Scientific Services (PSS) teams. Our service maintains high standards of excellence, expertise, and cGMP compliance.
What can Eurofins offer you?
* Developmental opportunities and career progression
* The chance to work with a world-leading pharmaceutical and biotechnology company
* Accessible location
* Private Medical Insurance
* Income protection and life assurance
* Annual discretionary bonus
* Free onsite parking
* Use of the canteen facilities on the client site
* Additional annual leave with continued service
* The opportunity to work on products helping to save lives worldwide
The primary purpose of this role is to develop, optimize, validate, and transfer analytical methods according to regulatory guidelines. You will participate in a PSS team to ensure quality, productivity, and client requirements are met.
Job Responsibilities
* Complete analytical data collection, interpretation, and characterization of compounds with proper documentation.
* Support development and optimization of analytical methods.
* Provide technical support for new product introductions, including method development, validation, and transfer.
* Lead troubleshooting of analytical challenges.
* Communicate project progress with clients and meet project timelines.
* Ensure project delivery within timeframes and compliance with quality and safety standards.
* Provide training on new practices as needed.
* Review and approve SOPs, reports, validation protocols, and risk assessments.
* Adopt ALCOA+ principles and ensure team compliance with GMP.
* Verify analytical results and material acceptance criteria.
* Lead laboratory investigations and project design.
* Identify and investigate out-of-specification results, designing root cause experiments and retest plans.
* Manage projects from concept to delivery, providing regular updates.
* Communicate regulatory issues to senior team members.
Qualifications and Experience
* Honours degree in Chemistry or related field.
* Minimum 5 years in an analytical laboratory.
* Leadership skills are advantageous.
* Extensive knowledge of method development and validation.
* Experience analyzing APIs, raw materials, and excipients using techniques like HPLC, GC, IR, LC-MS, ICP-OES, and particle size analysis.
* Proficiency with laboratory instruments and software.
* Strong problem-solving and troubleshooting skills.
* Competent with IT systems and Microsoft Office.
* Understanding of laboratory procedures, data integrity, and regulatory requirements.
* Knowledge of validation and transfer procedures.
This role involves a 39-hour workweek on a day shift. Benefits include pension, medical and health insurance, and bonuses. Eurofins provides support and a collaborative environment. Join us to be part of a global leader in life sciences testing and insourcing solutions.
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