26 ago
|
Pqe Group
|
Barcelona
26 ago
Pqe Group
Barcelona
Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries? PQE Group
has been at the forefront of these industries
since 1998
, with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas.
We are currently seeking an experienced
Commissioning, Qualification & Validation (CQV) Lead
in
Barcelona
. This role will focus on the
qualification and validation of equipment and systems in biotechnological production facilities.
Responsibilities include, but are not limited to:
- Execute
commissioning, qualification, and validation activities
for pharmaceutical/biotech equipment and systems
- Prepare, review, and execute
C&Q; and validation documentation (URS, DQ, IQ, OQ, PQ protocols, test scripts, and summary reports)
- Collaborate with cross-functional teams
(Engineering, QA, Validation, Manufacturing)
to ensure compliance with
GMP, regulatory guidelines, and project timelines
- Review
technical documentation, P&IDs;, FAT/SAT protocols, and vendor manuals
- Identify, troubleshoot,
and document deviations, ensuring timely resolution
- Ensure all activities meet
GMP, FDA, EMA, and ICH requirements
- Provide project updates and progress reports to stakeholder
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field
- At least 5 years of experience
in IQ/OQ/PQ protocol development and execution and C&Q; for pharmaceutical/biotech facilities, including construction of production plants
- Strong knowledge of GMP, FDA, and EU regulations
- Excellent analytical, problem-solving, and communication skills
- Ability to work independently and collaboratively in a project environment.
- Spanish native, English fluent (at least B2)
- Salary starting at 40,000€ gross per year
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with
📌 CQV Lead (Barcelona)
🏢 Pqe Group
📍 Barcelona