Method Development & Validation Specialist
Inactive
Eurofins - Career
Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client’ site, utilizing their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!
Method Development & Validation Specialist
Job Description
- Collect information required for the analytical target profile from Project (analytical lead, project manager, product owner…).
- Propose and test candidate analytical techniques potentially able to meet expected needs.
- Develop robust & efficient analytical methods by aQBD using classical LC-UV method with no/limited assistance utilizing modern & state‑of‑the‑art statistical approaches to bring them to successful validation.
- Collect data from development and take decisions / propose solutions based on obtained results. Prepare support and present development status in technical team review meetings.
- Assure that complex technical data are reported with scientific excellence and communicate the outcome of the analytical activity to team/supervisor/customer.
- Understand and master all regulatory requirements pertaining to analytical method performance.
- Contribute and/or collaborate to analytical method validation/co-validation/transfer both internally or external labs.
- Design complex study designs and write associated Quality documents (protocols, reports, procedures).
- Document results in laboratory notebooks according to established GDP procedures.
- Advise supervision and customer when facing issues and propose options to meet timeline/define new timeline.
- Participate in method comparability/equivalence studies to enable continuation of the analytical method lifecycle.
- Interact with cross‑functional teams of analytical experts with internal/external labs/suppliers.
- Identify risks, issues and opportunities and communicate to supervisor and customer.
- Collaborate to investigations in complex analytical issues corresponding to atypical or out‑of‑specification/trend test results and instrumentation/methodology issues.
Qualifications
- Holds a master’s degree in chemistry/Analytical chemistry or a similar field.
- We are looking for candidates who have more than 4 years of experience.
- Strong technical knowledge of various analytical techniques, especially Liquid Chromatography (LC-UV) with significant experience in development validation/verification/transfer and troubleshooting.
- Understanding of interactions with other disciplines: Formulation, Process Development, Regulatory Affairs, QA.
- Strong knowledge of compendial and other applicable regulations.
- Fluent communication skills in English; French is nice to have.
- Basic project management skills.
- The candidate must show Ownership, critical mindset and out of the box thinking.
- Ability to operate in certified environments.
- Eagerness to learn new analytical techniques.
- Knowledge of new analytical strategies (ICH Q14, QbD…).
Additional Information
- A full-time (40hours/week) Monday – Friday job.
- Job location: Braine l'alleud
- A Permanent contract with flexible working hours.
- Work in a fast-growing international organization.
- Meal Vouchers 8 Euro/Working Day.
- Eco-Cheques +/- 250 Euro/Year.
- DKV Hospitalization insurance.
- Additional 12 ADV days.
- A company well-being program targeting both mental and physical well-being.
- A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment.
- Personal development through learning on the job and additional trainings.
