Process Expertise & Validation Specialist

Job content

Make your mark for patientsWe are looking for a Process Expertise & Validation Specialist who is analytical, innovative and a team player to join us in our Process Expertise & Validation team, based in our site office in Bulle, Switzerland.About The RoleAs a Process Expertise & Validation Specialist you will support process troubleshooting and continuous improvement for the chemical & pharmaceutical processes by ensuring the carry-out of process & cleaning validations for all chemical & pharmaceutical products of Bulle site.Who You’ll Work WithYou will work in a team of 6 colleagues who share a very collaborative spirit.What You’ll Do

• Lead process validation and cleaning validation/verification, including the definition of the validation strategy :
• Drive and write validation risk assessments, change-over protocols and change controls for current and new processes as Validation & Process Expert.
• Write validation plans, protocols and reports.
• Provide expertise in validation and process knowledge during investigations, Change Controls and projects for chemical and pharmaceutical processes.
• Implement new processes and support the Tech Transfer activities for chemical and pharmaceutical processes.
• Lead and ensure the implementation of CPV for new processes: Definition of the initial CPV plan, creation of the initial CPV report.
• Act as a Subject Matter Expert (SME) for selected topics such as Process Validation, Cleaning Validation, CPV, etc.

Interested? For this role we’re looking for the followingeducation, experienceandskills

• Master’s degree in a relevant Life Sciences engineering discipline and 3+ years operational experience in chemical and/or pharmaceutical manufacturing.
• Proven experience in multiproduct facilities, process validation and cleaning validation.
• Able to work in a GMP environment, with a strong manufacturing mindset.
• Excellent communication skills, fluent in French and English and capable to create a strong relationship with business partners and stakeholders.
• Ability to work with large amounts of data and provide complex analyses. Knowledge of statistical software is a plus (Minitab, JMP, R …etc.).

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work for us?At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.