Client: Leading Pharmaceutical Company Location: Multiple Sites (with 50% travel) Role Overview We are seeking highly experienced Subject Matter Experts (SMEs) across key manufacturing domains: Lyophilizer (Freeze Dryer) Operations . Each SME will be responsible for providing deep technical expertise, process optimization, and compliance oversight in their respective area. The role requires extensive travel (~50%) to support multiple facilities, audits, and technology transfers. Key Responsibilities (per area) Should have knowledge about the process cycle of a Freeze Dryer. Should have capability for installation and commissioning of Freeze Dryer. Should have knowledge about selection of material for Freeze Dryer based on product. Should have knowledge about instrumentation and operation of components installed on Freeze Dryer. Should have knowledge about critical components like compressor, vacuum pumps, LRP, CIP circulation pump, silicon oil circulation pump, valves, hydraulic station, Alus, pizza door. Should have hands-on experience in operation and maintenance of Freeze Dryers of various makes. Should have knowledge about complete process from raw material sampling/dispensing to finished goods (sampling/dispensing/manufacturing/filtration/filling/FD loading/FD unloading/capping/packing). Common Responsibilities Travel (~50%) to our facilities for audits, training, troubleshooting, and technology transfer. Collaborate with R&D, QA, and manufacturing teams to ensure process excellence. Author and review technical documentation, validation protocols, and reports. Ensure compliance with global regulatory standards (FDA, EMA, WHO). Mentor and train operators and technical staff. Qualifications Bachelor’s/Master’s in Pharmacy, Biotechnology, Chemical/Mechanical Engineering, or related discipline. 8–12 years of hands-on experience in the respective domain -freeze dryers- Lyophilizer). Proven expertise working with different makes/models of equipment or directly with OEMs . Strong knowledge of cGMP, regulatory requirements, and validation practices. Excellent communication, analytical, and cross-functional collaboration skills. Willingness to travel up to 50% of the time. . Skillset Required: Engineering, Projects, Lyophilliser, freeze dryers
Job Title
Manager /Sr. Manager/AGM- SME (Freeze Dryer-Lyophilization) )