Cqv Engineer Staff Ii

Caiü; Italia; In loco; EUR 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

Caiü sta cercando un CQV Engineer Staff II per supportare la Commissioning, Qualification e Validation presso strutture farmaceutiche in Italia. Il ruolo prevede redazione di protocolli, esecuzione in campo e sviluppo di report riepilogativi presso i siti clienti.

Richiesta forte attenzione ai dettagli, esperienza in ambienti regolamentati FDA e leadership cGMP, con disponibilità a viaggiare sia in Italia sia all’estero. Laurea in campi ingegneristici o scientifici valorizzata.

Competenze

• Desiderata: laurea in campo scientifico o ingegneristico o equivalente.
• Esperienza minima 4–8 anni in commissioning e/o qualification in settore regolato FDA.
• Conoscenza Baseline Guide 5 è un plus.

Mansioni

• Supporto documentazione per Commissioning, Qualification e Validation di strutture/impianti farmaceutici.
• Redazione ed esecuzione di protocolli, verifiche in campo e sviluppo di report riepilogativi presso siti clienti.

Conoscenze

Attention to detail

Multi-tasking

BS/MS in science or engineering

FDA regulated industry experience

CQV/Commissioning qualifications

cGMP leadership

Problem solving

Independent work

Walkdowns & testing

Life sciences manufacturing

Isolators protocol execution

VHP cycle development

GMP knowledge

MS Word & Excel

English proficiency

Travel availability in Italy/abroad

Formazione

BS in science/engineering

MS in science/engineering

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

CQV Engineer Staff II

Azienda : Caiü, Tipo Lavoro : Full Time, Italy

Descrizione Lavoro - CQV Engineer Staff II

We are now seeking a CQV Engineer to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.

The role of a CQV Engineer in CAI is to:

• Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
• Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.

Position Requirements

• High attention to detail
• Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands‑on experience
• Minimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
• Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
• Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues deadlines
• Ability to work independently, while quickly building and nurturing a project team
• Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
• Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
• Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
• Familiarity with Baseline Guide 5 (Second Edition) a plus
• Expected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge
• Expertise in Microsoft Word and Excel
• Excellent oral and written English are required.
• Available for travel in Italy and abroad.

La selezione rispetta il principio delle pari opportunità (l. 903/77)

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Informazioni sull'azienda

Caiü

Rely on CAI for commissioning services that advance life sciences and mission critical facilities around the world. Contact us to achieve accelerated excellence.