Duties & Responsibilities A leading pharmaceutical organisation is seeking an experienced Manufacturing Technology Specialist on a 12-month contract to provide technical leadership across technology transfer, validation, and process optimisation initiatives with Contract Manufacturing Organisations (CMOs).
Key Responsibilities:
Lead and manage technology transfer activities, including protocol development and execution (PQ, PPQ, CPV, scale-up batches). Conduct technical gap assessments of CMOs (facility, utilities, equipment, capabilities). Provide technical oversight during validation and commercial batches to ensure consistent product quality. Drive process optimisation and cost-efficiency initiatives, including yield improvement and cycle-time reduction. Support alternative vendor development (AVD) for APIs, intermediates, and packaging materials. Investigate and resolve deviations, OOS/OOT, and technical issues, ensuring timely CAPA implementation. Compile and review technical documentation to support regulatory submissions and ensure cGMP compliance. Collaborate cross-functionally with Quality, Regulatory Affairs, Supply Chain, and Product Development teams.
Minimum Requirements:
Bachelor’s degree in Pharmacy, Chemical Engineering, Industrial Engineering, Mechanical Engineering, or related field. 5–10 years’ experience in pharmaceutical manufacturing. Proven experience in technology transfer, validation (IQ/OQ/PQ/PPQ), and process optimisation. Strong understanding of cGMP, regulatory compliance (SAHPRA, WHO, FDA, etc.). Experience working with CMOs and/or managing external manufacturing partners advantageous. Sound knowledge of SAP and strong technical documentation skills. Excellent problem-solving, communication, and stakeholder management abilities.
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