Process and Clinical Validation Consultant
PQE Group
Job Description
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 a Validation Consultant with strong expertise in Process Validation and Cleaning Validation to support pharmaceutical/biotech activities in Barcelona.
Responsibilities include, but are not limited to:
- Plan, execute, and document Process Validation and Cleaning Validation activities
- Author, review, and approve validation protocols and reports
- Perform user reviews and ensure compliance with applicable GMP and regulatory requirements
- Support and contribute to CSV (Computer System Validation) activities
- Deliver training sessions on CSV and validation-related topics to internal teams and stakeholders
- Collaborate with cross-functional teams (QA, Production, Engineering, IT) as needed
- Ensure validation activities are conducted in accordance with company procedures and regulatory guidelines (GMP, EMA, FDA where applicable)
Required Qualifications:
- Minimum 3 years of experience in Process Validation and/or Cleaning Validation within the pharmaceutical or biotech industry
- Proven ability to work independently with minimal supervision
- Solid experience in writing and executing validation protocols and reports
- Good knowledge of GMP regulations and validation best practices
- Experience with user requirement reviews
- Knowledge of CSV principles and ability to train others on CSV topics
- Strong organizational, documentation, and communication skills
- Fluent in English and Spanish
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.