Job Title

Client: Leading Pharmaceutical Company Location: Multiple Sites (with 40-50% travel) Role Overview The SME – Filling will be responsible for overseeing and executing aseptic filling and lyophilization operations in the sterile production area. The role requires strong technical expertise in aseptic processes, equipment operation, troubleshooting, and compliance with cGMP and regulatory requirements.The role requires extensive travel (~40-50%) to support multiple facilities, audits, and technology transfers. Key Responsibilities Expertise in operation of below process and equipment’s: To handle aseptic and lyophilisation area. To handle process like filtration, filling, Lyophilizer loading and unloading, lyophilisation process and capping. To handle the process equipment’s and its trouble shooting like filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP pass box, mobile LAF etc. Exposure to perform the Smoke study of entire filling line and process like filtration, filling assembly, filling operation, aseptic intervention during filling, loading and unloading, smoke study in static and dynamic conditions. Knowledge about aseptic practices, aseptic behaviours, media fill simulation, aseptic gowning and de-gowning process, aseptic area cleaning and sanitization process , personal gowning qualification. To handle preparation and execution of qualification protocol of new equipment, area cleaning and sanitization etc. Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism. Exposure for User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification. Experience for preparation of batch manufacturing records. To handle the QMS documents like change control, CAPA, risk assessment, deviation etc. Common Responsibilities Travel (~40-50%) to our facilities for audits, training, troubleshooting, and technology transfer. Collaborate with R&D, QA, and Engineering 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, or related discipline. 10+ years of hands-on experience in the respective domain - sterile Manufacturing. 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 40-50% of the time.