Commissioning & Qualification PMO

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 2000 employees, 45+ nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means joining a multicultural and challenging company with many local and international projects, and colleagues from all over the world.

Due to constant growth, we are looking for a Commissioning & Qualification PMO to join our team in Barcelona, Spain.

Responsibilities include, but are not limited to the following:

• Design & Lead the Project PMO Team according to the Portfolio phases.
• Set up portfolio and project governance frameworks, including: Meeting landscape, Reporting standards, Operating models, RACI definitions, Stakeholder management, Auditing and standard process definitions.
• Oversee and challenge project schedule and costs.
• Assure consistency of technical, operational and transformation schedules.
• Commissioning & Qualification for Facility, Process, HVAC, Clean Room and Utility Services (monitoring FAT, SAT and DQ activities).
• Validation / Qualification for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized Pharmaceutical guidelines (EU / FDA GMP and ISPE, GAMP).
• Drafting, verification and execution of protocols and qualification tests (FAT, SAT, IQ, OQ, PQ).
• Drafting of thermal validation study protocols.
• Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments, e-ValPro).

Requirements:

• 5+ years of experience in CQV as a Project Manager within complex and dynamic environments.
• Resource shall have experience in CQV activities in pharmaceutical / biotech industry to support current phase of the CAPEX project.
• Technical Degree (Engineering, Chemistry, Pharmacy, Biotechnology, Informatics, Physics, Mathematics, or related).
• Availability to travel.
• Fluency in English (at least B2 / C1 level), native in Spanish (C1 / C2).
• Strong Analytical, Organizational and Team Management skills.

Location: Barcelona, Spain

Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

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.