Process & Cleaning Specialist
for the site Borgo San Michele LT, Italy
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.
Your key responsibilities
* Manage and optimize the cleaning processes of production equipment, ensuring compliance with GMP regulations and company procedures.
* Collaborate with manufacturing, quality and engineering teams to develop, validate and monitor cleaning processes (CIP/SIP and manual).
* Draw up and update the technical documentation (SOP, validation protocols, reports) relating to cleaning activities.
* Support investigation activities in case of deviations or non-conformities related to cleaning processes.
* Participate in the definition and implementation of cleaning validation and cleaning verification strategies.
* Contribute to the continuous improvement of processes through trend analysis and identification of corrective/preventive actions.
* Provide support during internal and external audits (regulatory and clients’) regarding cleaning aspects and related processes.
Your profile
* Degree in Chemistry, Industrial Chemistry, Chemical Engineering, or related scientific disciplines.
* Previous experience (at least 2-3 years) in a similar role in the pharmaceutical or biotechnology sector.
* In-depth knowledge of GMP regulations and EMA/FDA guidelines on cleaning validation.
* Familiarity with the analytical techniques used to verify cleanliness (e.g. TOC, HPLC, visual residues).
* Document management and technical drafting skills in the regulatory field.
* Excellent analytical skills, problem solving and orientation towards continuous improvement.
* Good knowledge of English, written and spoken.
* Aptitude for teamwork and cross-functional collaboration.
Your motivation
Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions ratherthan problems? What are you waiting for? We would be happy to explain our corporate benefits in a personalconversation!If you have any questions, I - Chiara Fanasca / Human Resources - will be happy to help you:Haupt Pharma Latina S.r.l. • Member of the Aenova Group • Strada Statale 156 dei Monti Lepini • 04100 Borgo San Michele LT, Italy #J-18808-Ljbffr