Requirements: English
Company: ALTEN Italia
ALTEN Italy, a leading force in the IT, Engineering and Life Sciences industries, is on the lookout for a vibrant and driven Techincal Unit Manager with a strong experience in CQV to join our dynamic team in the Life Sciences division. At ALTEN, we believe in the power of talent to drive innovation and success, and we''re looking for an individual who shares our passion for connecting exceptional professionals with rewarding opportunities.
ALTEN Group
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.
What are we looking for?
As a Technical Unit Manager with CQV expertise, you will play a key role in ensuring that pharmaceutical equipment, systems, and processes meet the highest standards of safety, reliability, and compliance. This role is ideal for a seasoned professional with a minimum of 10 years of experience in CQV who can independently manage complex projects and client interactions, especially during the bidding process.
Key Responsibilities:
- Project Leadership: Lead CQV projects from inception to completion, ensuring all deliverables meet regulatory and client expectations.
- Bid Management:
- Analyze and interpret technical requests from clients.
- Identify risks and define key assumptions.
- Develop the best technical approach tailored to client needs.
- Define deliverables and estimate workload effectively.
- Manage the bidding process autonomously, including presale activities and presenting proposals to clients.
- Technical Expertise: Oversee commissioning, qualification, and validation activities, ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
- Risk Assessment: Identify and mitigate risks associated with equipment, processes, and systems to ensure seamless project execution.
- Stakeholder Engagement: Collaborate with clients, project teams, and cross-functional stakeholders to ensure alignment and satisfaction.
- Continuous Improvement: Stay updated on industry trends, regulatory requirements, and best practices to provide cutting-edge solutions.
Qualifications:
- Minimum of 5 years of experience in CQV within the pharmaceutical or life sciences sector.
- Proven expertise in managing commissioning, qualification, and validation projects independently.
- Strong ability to manage bids autonomously, including presales and client presentations.
- Excellent analytical skills to understand technical requests, identify risks, and define project assumptions.
- Deep understanding of regulatory requirements (e.g., GMP, FDA, EMA) and validation standards.
- Exceptional communication and interpersonal skills to effectively engage with clients and stakeholders.
- Bachelors or Masters degree in engineering, life sciences, or a related field.
- Native level of Italian and fluency in English is required.
- Availability to visit clients within the perimeter.
What We Offer:
- Competitive salary based on experience.
- Company car as part of the benefits package.
- Opportunities for career development in a dynamic and growing international company.
- A collaborative and inclusive work environment.
If you are passionate about quality, have a strong background in validation, and are looking for a challenging and rewarding opportunity, we will be waiting for you!