This position involves leading all qualification and validation activities to support the commercialization of an API manufacturing process that meets current good manufacturing practices (cGMP) standards. The validation engineer will lead the development of the validation master plan (VMP). VMP processes and procedures will include, but is not limited to equipment, manufacturing processes, quality control testing and all related vendors. Duties will include leading the development and execution of qualification and validation protocols to ensure that all equipment and processes/procedures meet API manufacturing specifications. The validation engineer will also coordinate the drafting and finalizing of standard operating procedures.
Scope of Work
· PQM+ is seeking a validation engineer consultant to:
o Lead validation activities supporting commercial cGMP API production.
o Lead development of master validation plan (including all qualifications and validations supporting GMP API manufacturing processes, subprocesses, equipment, quality control testing and others)
o Develop and execute API synthesis validation protocols and compile reports.
o Coordinate drafting and finalizing standard operating procedures for all API manufacturing processes, subprocesses, equipment, quality control testing and others.
o Lead the development, execution and reporting of design, installation, operational and performance qualifications (DIOPQ) protocols.
o Conduct vendor qualifications.
o Lead development of user requirement specifications and software validations
Qualifications
· Bachelor’s in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related degrees. Advanced degree preferred.
· Minimum of 10 years of validation experience within pharmaceutical industry and GMP environment validating processes and commercializing products (API experience preferred)
· Ability to communicate effectively with staff, internal and external stakeholders.
· Experience in data analysis and statistics (e.g. design of experiment, response surface analysis and Six Sigma are a plus)
· Experience in writing qualification and validation protocols.
· Experience carrying out qualifications and validations.
· Ability to work independently, as well as with cross-cultural and cross-functional teams.
· Willingness to travel to South Africa as necessary.
· Regular written progress updates on activities
· Validation protocols
· Qualification protocols
· Validation and qualification reports
· Standard operating procedures
Please send CV, 3-References, and Hourly Rate in US$ to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of April 26,2024. When submitting your application, write “Validation Engineer Consultant – PQM+ Core TB – South Africa in the email Subject Line.
Background
The Promoting the Quality of Medicines Plus (PQM+) program[1] is a six-year (September 27, 2019 - September 26, 2025) U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance to national regulatory authorities and health product manufacturers in a number of African and Asian countries.
PQM+ is currently assisting an active pharmaceutical ingredient (API) manufacturer in South Africa with technology transfer from a United States based organization. Technical assistance is required for technology transfer, scale up and commercialization of the API synthesis process. PQM+ seeks to hire a validation engineer consultant to provide hands-on assistance in active pharmaceutical ingredient (API) synthesis qualification and validation activities from scale up through commercial scale manufacturing.
[1] https://www.usp.org/sites/default/files/usp/document/our-impact/pqm/pqm-plus-overview-brochure.pdf
