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  • Commissioning, Qualification, and Validation (CQV) Specialist Italy
  • ALTEN in Italy, , Italy
  • jobs
  • 6 days ago

jobs description

ALTEN Italy, a leading force in the IT, Engineering and Life Sciences industries, is on the lookout for a Commissioning, Qualification, and Validation (CQV) Specialist for our Life Sciences division.

Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.

Location: Tuscany/Bologna

We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Specialist to join our dynamic team. The ideal candidate will have 3-6 years of experience in the pharmaceutical industry, with expertise in commissioning, qualification... and validation processes.

Responsibilities:
• Lead commissioning, qualification, and validation activities for new and existing pharmaceutical manufacturing equipment and processes.
• Develop and execute validation protocols (IQ, OQ, PQ) in accordance with regulatory requirements (FDA, EMA, etc.).
• Perform risk assessments and develop mitigation strategies to ensure compliance with quality standards.
• Collaborate with cross-functional teams, including engineering, quality assurance, and regulatory affairs, to ensure successful project execution.
• Provide technical expertise and support during regulatory inspections and audits.
• Continuously assess and improve validation processes to enhance efficiency and compliance.

Qualifications:
• Bachelor's or Master's degree in Engineering, Pharmacy, or related field.
• 3-6 years of experience in commissioning, qualification, and validation within the pharmaceutical industry.
• Strong understanding of cGMP regulations and guidelines.
• Experience with equipment qualification, process validation, and computerized systems validation.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
• Fluent in Italian (native proficiency) and proficiency in English.
• Ability to work independently and prioritize tasks in a fast-paced environment.

Benefits:
• Opportunity to join a growing and dynamic team.
• Opportunity for professional growth and development within a global international company with diverse projects.
• Collaborative and inclusive work environment.
• Continuous trainings, opportunities to grow and develop a career in the field.

If interested, please share your CV with us and let's have a chat
Italy

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