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?
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 cross-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 audit-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 problem-solving and analytical skills with attention to detail
* Excellent communication skills in
English
(written and spoken)
* Ability to work independently and collaboratively in a fast-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 Please submit your resume detailing your relevant experience and qualifications.