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CQV Project Manager

hace 2 semanas

Valladolid, Valladolid, España PQE Group A tiempo completo

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) Project Manager
in
León, Spain
. This role will focus on the
qualification
and
validation
of
equipment
and
systems
in
biotechnological production facilities
.

Responsibilities include, but are not limited to:

  • Lead and
    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
    stakeholders
    .

Required Qualifications:

  • Bachelor's degree
    in
    Engineering, Life Sciences
    , or related field.
  • Proven
    experience
    in
    CQV
    for
    pharmaceutical/biotech facilities
    , including
    construction of production plants
    .
  • Strong knowledge of
    GMP
    ,
    FDA
    , and
    EU regulations
    .
  • Experience in
    IQ/OQ/PQ protocol development
    and
    execution
    .
  • Excellent
    analytical
    ,
    problem-solving
    , and
    communication skills
    .
  • Ability to work
    independently
    and
    collaboratively
    in a
    project environment
    .
  • Fluent in
    English
    and
    Spanish
    (
    written and spoken
    ).

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 the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation
. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.