Process Validation Engineer Job Vacancy in Sumbawanga, Tanzania – Pharmaceuticals

Job Description

Position: Process Validation Engineer

Company: Novartis Tanzania

Location: Sumbawanga, Tanzania

Experience: 3-5 years in pharmaceutical process validation

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

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Engineering & Quality Assurance

Salary: SSP 2,500,000 – SSP 3,500,000 per month

Vacancies:1

Company Overview

Novartis Tanzania is a leading global healthcare company dedicated to improving patient outcomes through innovative medicines and advanced technologies. With a strong presence across East Africa, Novartis Tanzania operates state‑of‑the‑art manufacturing facilities, research laboratories, and a robust distribution network that serves both urban and rural markets. The company’s commitment to quality, compliance, and sustainable practices has positioned it as a trusted partner for healthcare providers, regulators, and communities throughout Tanzania. As part of its expansion strategy, Novartis Tanzania is investing in new production lines in Sumbawanga to increase local access to life‑saving therapies, creating a dynamic environment for professionals seeking career growth in the pharmaceutical sector. This role contributes directly to the company’s mission of delivering high‑quality products while adhering to stringent global standards, making it an exciting opportunity for candidates passionate about process validation and continuous improvement.

Job Overview

The Process Validation Engineer will lead the design, execution, and documentation of validation activities for new and existing manufacturing processes at Novartis Tanzania’s Sumbawanga facility. This position ensures that all processes meet regulatory requirements, internal quality standards, and industry best practices. Working closely with cross‑functional teams—including Production, Quality Assurance, Regulatory Affairs, and Engineering—the successful candidate will develop validation master plans, conduct risk assessments, and generate comprehensive reports that support product release and compliance. The role is pivotal in supporting Novartis Tanzania’s commitment to delivering safe, effective, and high‑quality pharmaceutical products to the Tanzanian market and beyond. For more information about Novartis Tanzania’s vision and values, visit tanzaniajobsearch.com.

Key Responsibilities

• Develop and maintain Process Validation Master Plans, protocols, and reports in accordance with ICH Q8, Q9, and Q10 guidelines.
• Design, execute, and analyze Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) studies for equipment and processes.
• Collaborate with Production and Engineering teams to identify critical process parameters and establish robust control strategies.
• Perform risk assessments using FMEA and HACCP methodologies to prioritize validation activities.
• Ensure all validation documentation is complete, accurate, and audit‑ready for regulatory inspections.
• Support technology transfer projects by providing validation expertise and ensuring seamless scale‑up from pilot to commercial production.
• Monitor post‑validation performance, analyze deviations, and implement corrective actions as needed.
• Maintain up‑to‑date knowledge of local Tanzanian regulatory requirements and global GMP standards.

Required Skills

• Strong understanding of pharmaceutical manufacturing processes, including sterile and non‑sterile production.
• Proficiency in statistical analysis tools (e.g., Minitab, JMP) and data interpretation.
• Excellent written and verbal communication skills for preparing clear validation reports.
• Ability to work independently and lead cross‑functional validation projects.
• Detail‑oriented mindset with a focus on compliance and quality.
• Effective problem‑solving skills and a proactive approach to continuous improvement.

Education

A Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related discipline is required. Advanced certifications in validation (e.g., Certified Validation Professional) or a Master’s degree are advantageous but not mandatory.

Experience

Applicants must have 3‑5 years of hands‑on experience in process validation within a GMP‑regulated pharmaceutical environment. Experience with equipment qualification, process analytical technology (PAT), and regulatory submissions is highly valued.

Salary

The position offers a competitive salary range of SSP 2,500,000 to SSP 3,500,000 per month, commensurate with experience and qualifications. Performance‑based bonuses and annual salary reviews are part of the compensation package.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company matching contributions.
• Paid annual leave, sick leave, and public holidays.
• Professional development allowance for certifications and conferences.
• Employee assistance program and wellness initiatives.

Training

• On‑boarding program covering Novartis quality systems, GMP regulations, and company culture.
• Continuous training in advanced validation techniques, data analytics, and regulatory updates.
• Mentorship opportunities with senior validation experts and global teams.

Working Environment

Novartis Tanzania provides a collaborative, safety‑first workplace equipped with modern laboratories, validation suites, and cutting‑edge manufacturing equipment. The Sumbawanga facility adheres to strict environmental and safety standards, fostering a culture of excellence and innovation. Employees enjoy a supportive atmosphere that encourages knowledge sharing, teamwork, and career progression.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining relevant experience through the online portal on the Novartis Tanzania careers page. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment.

Equal Opportunity Statement

Novartis Tanzania is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, age, disability, ethnicity, religion, or sexual orientation. All qualified applicants will receive consideration for employment without regard to any protected characteristic.