Process & Cleaning Specialist

Aenova Group; Borgo San Michele; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Borgo San Michele, Italy, is looking for a Process & Cleaning Specialist. The successful candidate will manage cleaning processes, optimize production compliance with GMP regulations, and support audit activities. Candidates should have a degree in Chemistry or related fields and 2-3 years of relevant experience. Excellent analytical and problem-solving skills are essential. Join a dynamic team and contribute to improving health outcomes.

Competenze

• At least 2-3 years' experience 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 analytical techniques used to verify cleanliness.

Mansioni

• Manage and optimize cleaning processes of production equipment.
• Collaborate with teams to develop, validate, and monitor cleaning processes.
• Update technical documentation relating to cleaning activities.

Conoscenze

GMP regulations knowledge

Analytical skills

Problem-solving

Teamwork

Continuous improvement orientation

Formazione

Degree in Chemistry, Industrial Chemistry, or related fields

Strumenti

TOC

HPLC

Descrizione del lavoro

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.

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 creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation!

If you have any questions, I - Chiara Fanasca / Human Resources - will be happy to help you: [phone]