Process & Cleaning Specialist

Site:
Borgo San Michele LT, Italy
Aenova is one of the world's leading contract manufacturers and developers for the pharmaceutical industry, operating 15 sites worldwide with 4,000 employees. Latina is a leading centre of excellence in sterile liquid production and is investing strategically to become a premier European hub.

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.

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