CQV Engineer Lisboa

CQV Engineer
Lisboa
Lisboa, Lisboa, Portugal

ALTEN Portugal , a leading force in the IT, Engineering and Life Sciences industries, is on the lookout for CQV Engineer to join our dynamic team in the Life Sciences division.

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.

Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?

The Role:

As a CQV Engineer , you will be responsible for the execution and oversight of Commissioning, Qualification, and Validation (CQV) activities within regulated pharmaceutical environments . This includes equipment and process qualification , as well as computer system validation (CSV) activities to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards (e. g. , FDA, EMA, GAMP 5).

Key Responsibilities:

• Develop, review, and execute Validation Master Plans (VMPs) , IQ/OQ/PQ protocols , and traceability matrices
• Lead Computer System Validation (CSV) initiatives, including risk assessments, URS, FS/DS, testing protocols, and data integrity reviews
• Support GMP compliance efforts during facility and equipment commissioning and qualification
• Work closely with
  - functional teams including QA, Engineering, and IT to ensure successful implementation and documentation of validation strategies
• Investigate and resolve deviations and support change control activities
• Prepare technical reports and ensure documentation is
  - ready and compliant with internal procedures and regulatory expectations

Your Profile:

• Bachelor's or Master’s degree in Pharmaceutical Sciences , Biotechnology , Chemical Engineering , Biomedical Engineering , or related field
• Minimum 1–3 years of experience in CQV and/or CSV within the pharmaceutical or biotech industry
• Strong understanding of GMP , GAMP 5 , Annex 11 , and 21 CFR Part 11 regulations
• Hands-on experience with equipment qualification , process validation , and computerized system validation
• Strong
  - solving and analytical skills with attention to detail
• Excellent communication skills in English (written and spoken)
• Ability to work independently and collaboratively in a
  - paced environment

If you're looking to launch your career in the pharmaceutical industry and are passionate about quality and validation, we’d love to hear from you!

If you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you! Please submit your resume detailing your relevant experience and qualifications.