Biopharmaceutical Process Validation Engineer Job Vacancy in Kairouan, Tunisia – Pharmaceutical Manufacturing & Quality Assurance

Job Description

Position: Biopharmaceutical Process Validation Engineer

Company: Sanofi

Location: Kairouan, Tunisia

Experience: 5-8 years in biopharmaceutical process validation or related GMP manufacturing environment

Education: Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or related field

Employment Type: Full-time

Industry: Pharmaceutical Manufacturing & Quality Assurance

Department: Technical Operations / Manufacturing Science & Technology (MSAT)

Vacancies:1

Company Overview

Sanofi is a leading global biopharmaceutical company focused on human health, dedicated to preventing, treating, and curing disease. With a rich heritage spanning over a century, Sanofi operates in more than 100 countries, employing over 100,000 people worldwide. Our mission is to chase the miracles of science to improve people’s lives. In Tunisia, Sanofi has established a significant presence, contributing to the local healthcare ecosystem through innovative medicines, vaccines, and now, advanced manufacturing capabilities. Our new state-of-the-art bioprocessing facility in Kairouan represents a major investment in Tunisia’s pharmaceutical sector, focusing on the production of complex biological medicines. This expansion creates exciting career opportunities in Tunisia for professionals passionate about science and manufacturing excellence. We are committed to fostering a diverse and inclusive workplace where employees can grow and contribute to meaningful work that impacts patients globally.

Job Overview

We are seeking a highly skilled and detail-oriented Biopharmaceutical Process Validation Engineer to join our Technical Operations team at the new Kairouan bioprocessing facility. This critical role is central to ensuring our manufacturing processes are robust, reliable, and compliant with global regulatory standards (FDA, EMA, etc.). The successful candidate will be responsible for designing, executing, and documenting validation protocols for upstream and downstream bioprocessing unit operations, including fermentation, cell culture, purification, and formulation. This position offers a unique job vacancy in Tunisia at the forefront of advanced therapeutic manufacturing. You will work cross-functionally with Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs to transfer and validate processes from development to commercial scale. This role is pivotal in guaranteeing product quality and patient safety, making it a cornerstone of our operational success. For more jobs in Tunisia across various sectors, visit https://tunisiajobsearch.com.

Key Responsibilities

• Develop, author, and execute comprehensive validation protocols (Process Performance Qualification – PPQ, Continued Process Verification – CPV) for biopharmaceutical manufacturing processes.
• Lead risk assessments (e.g., FMEA) to identify and mitigate process risks during validation activities.
• Analyze validation data using statistical tools to demonstrate process capability, robustness, and consistency.
• Author and review validation summary reports and associated documentation for regulatory submissions.
• Provide technical expertise during regulatory inspections and internal audits related to process validation.
• Collaborate with process development scientists to ensure validation strategies are incorporated early in the product lifecycle.
• Support manufacturing investigations (deviations, OOS) related to process performance and provide validation perspective.
• Maintain current knowledge of global regulatory guidelines (ICH, FDA, EMA) pertaining to process validation.
• Train manufacturing and quality personnel on validated processes and control strategies.
• Contribute to the continuous improvement of validation methodologies and site validation master plans.

Required Skills

• In-depth knowledge of biopharmaceutical process validation principles (Stage 1, 2, 3) per FDA and EMA guidelines.
• Strong understanding of cGMP, ICH Q7, Q8, Q9, Q10, and Q11 guidelines as they apply to biologics manufacturing.
• Proficiency in statistical analysis software (JMP, Minitab) and data trending techniques.
• Excellent technical writing skills for protocols, reports, and regulatory documents.
• Strong problem-solving and root cause analysis abilities.
• Effective communication and collaboration skills to work across multiple disciplines.
• Project management skills with the ability to manage multiple validation projects simultaneously.
• Fluent in English and French; Arabic is a strong asset.

Education

A minimum of a Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a closely related scientific field is required. A Master’s degree or PhD is highly preferred. Additional certifications in Process Validation, Quality Assurance, or Regulatory Affairs are considered a significant advantage.

Experience

A minimum of 5-8 years of direct hands-on experience in process validation within a biopharmaceutical or pharmaceutical GMP environment is essential. Candidates must have proven experience with mammalian cell culture processes, purification (chromatography, filtration), and/or formulation. Experience with tech transfer and scale-up activities from pilot to commercial scale is highly desirable. Prior involvement in pre-approval inspections (PAI) and interactions with health authorities is a plus.

Benefits

• Competitive salary and comprehensive benefits package aligned with international standards.
• Performance-based annual bonus and long-term incentive plans.
• Extensive health, dental, and life insurance coverage for employee and family.
• Generous paid time off, including vacation, sick leave, and public holidays.
• Continuous professional development opportunities and access to global Sanofi training platforms.
• Contribution to a company pension plan.
• Relocation assistance for candidates moving to Kairouan.
• On-site wellness programs and recreational facilities.

Training

• Comprehensive onboarding program covering Sanofi processes, safety, and quality systems.
• Specialized technical training in advanced bioprocessing technologies and validation methodologies.
• Leadership and management development programs for career progression.
• Regulatory affairs and compliance training updates.
• Sponsorship for relevant external conferences and workshops.
• Cross-functional project team participation for broad business exposure.

Working Environment

You will work in a modern, world-class bioprocessing facility equipped with the latest technology. The environment is dynamic, collaborative, and focused on scientific rigor and quality. Safety and compliance are paramount. You will be part of a multicultural team of experts dedicated to producing life-changing medicines. We promote a culture of innovation, integrity, and inclusion where every team member’s contribution is valued. This role represents a premier opportunity for employment in Tunisia in a high-tech industry.

Application Process

Qualified candidates are invited to submit their updated CV and a cover letter through the Sanofi global careers portal. The process includes an initial screening, followed by technical interviews with the hiring manager and team members, and a final interview with senior site leadership. We value diversity and encourage all qualified applicants to apply. For other Tunisia jobs and career resources, you may also explore https://www.eswatinijobsearch.com/.

Equal Opportunity Statement

Sanofi is proud to be an equal opportunity employer. All qualified applicants will receive consideration for hiring in Tunisia without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law. We are committed to building diverse teams and fostering an inclusive environment where every employee can thrive.