Empresa:

ALTEN Portugal

Descrição da Função

ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries, is on the lookout for two vibrant and driven Quality Assurance / Validation Consultants 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?

As a Validation Consultant, you will be responsible for the qualification of classified areas and critical utility systems (HVAC, compressed air, nitrogen), contributing to the delivery of a highly regulated, complex pharmaceutical project.

Key Responsibilities:

• Review of URS (User Requirement Specifications) and supplier qualification documentation;
• Drafting of risk-based SOPs to classify systems as Direct or Indirect Impact
• Proposal of procedures to evaluate instrument criticality and define calibration/maintenance periodicity;
• Preparation of Validation Master Plan (VMP) and DIOQ/PQ documentation;
• Review of SAT reports and technical documentation from system suppliers;
• Preparation and execution of DIOQ protocols, including:
• P&ID verification on site;
• Verification of instruments, switches, valves, rooms, utilities, etc.;
• Execution and reporting of Performance Qualification (PQ), including Environmental Monitoring evaluation;
• Contribution to the retrospective qualification of the Nitrogen system already in use;
• Finalization of all validation documentation and issuance of closure report.

Qualifications:

Senior Consultant - Requirements:

• Bachelor's or Master's degree in Engineering, Pharmacy, Life Sciences or related field;
• 6+ years of experience in system and equipment qualification in GMP environments;
• Proven leadership and autonomy in validation projects;
• Strong knowledge of GMP, GAMP 5, validation lifecycle, and pharmaceutical utilities;
• Fluent in English.

Junior Consultant - Requirements:

• Bachelor's degree in a relevant field (Engineering, Pharmacy, etc.);
• 1-2 years of hands-on experience in qualification/validation activities;
• Willingness to learn and grow under senior supervision;
• Familiarity with GMP and validation principles;
• Good level of English (written and spoken).

Location: Condeixa-a-Nova, Coimbra, Portugal (100% on-site)

Why Join Us?

• Possibility to work with cutting-edge technology in the Life Sciences industry
• Collaborative and dynamic work environment
• Possibility to join a top-leading company in the industry
• Continuous trainings
• Possibility to join different and interesting projects

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.

Observações

Coimbra (Portugal)