Senior Qualification Specialist

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.

Due to our continuous growth, we are currently seeking a highly motivated and experienced Senior Qualification Specialist to lead documentation and validation activities for the development of a new perfused fixed-bed bioreactor designed for the GMP manufacturing of extracellular vesicles (EVs). The ideal candidate brings a strong background in Quality Assurance within the engineering or biopharmaceutical industry, with proven expertise in regulatory compliance, process validation, and quality documentation.

Location: Charleroi, Belgium.

Responsibilities

Documentation Management:

• Create, review, and maintain essential Quality Assurance documentation, including Standard Operating Procedures (SOPs), validation plans, and technical reports related to bioreactor design and operations.
• Develop and implement a comprehensive documentation strategy that complies with GMP and regulatory requirements.

Validation Processes:

• Lead the validation efforts for the bioreactor system covering all phases, including Design Qualification (DQ), Installation Qualification (IQ).
• Collaborate with engineering teams to define and execute validation protocols.

Compliance Oversight:

• Conduct regular "inspections" of bioreactor processes to ensure adherence to GMP standards and internal quality guidelines.

Cross-Functional Collaboration:

• Work closely with engineering and project management teams to integrate quality considerations throughout the bioreactor development lifecycle.
• Assist in risk assessments related to bioreactor design and operation to enhance product quality and safety.

Qualifications

• Education: Bachelor's or Master's degree in Engineering, Biotechnology, Quality Assurance, or a related field.
• Experience: Minimum 6 years of experience in Quality Assurance (QA), preferably within the engineering or biopharmaceutical industry, with a focus on GMP manufacturing, process validation, and regulatory compliance.
• Industry Knowledge: Strong working knowledge of GMP/GLP, FDA/EMA regulations, and industry standards (e.g., ISO 13485, 21 CFR Part 11). Familiarity with bioreactor systems, particularly perfused fixed-bed bioreactors, and experience with extracellular vesicles (EVs) is a plus.
• Documentation & Validation Expertise: Proven experience in creating, reviewing, and maintaining QA documentation (SOPs, validation protocols, technical reports). Hands-on experience leading validation activities (DQ, IQ, OQ, PQ) for bioprocessing equipment. Ability to develop and implement GMP-compliant documentation strategies.
• Compliance & Auditing: Experience conducting internal inspections and ensuring adherence to GMP standards.
• Knowledge of risk assessment methodologies (e.g., FMEA) related to bioreactor design and operation.
• Language skills: Full professional proficiency in English required; knowledge of French is considered a strong asset.

Preferred Qualifications

• Experience with process automation and data integrity compliance in biomanufacturing.
• Knowledge of single-use bioreactor systems and EV production workflows.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial Talent Acquisition interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.