AbbVie Senior Engineer, Tech Ops (BIO) in Singapore, Singapore
* Responsible for biologics manufacturing process technical support and improvement initiatives for ongoing operations. May have responsibility for operations encompassing all aspects of cell culture and/or purification depending on required scope and experience. * Provides leadership to manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site. * Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s * Contact and consultant for process/equipment troubleshooting and investigation activities. * Actively promotes a culture of GMP and EHS compliance with all applicable policies and guidelines and supports risk assessment activities providing relevant technical knowledge. * Provides support to regulatory filings and audit activities. * Provides support for process cleaning/changeover strategies (CIP/SIP), media/solution preparation and benchtop analytics as required. * Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation.
* BS, MS or PhD in scientific or engineering filed with 3-6 years of related experience depending on degree. Target fields include chemical/biochemical engineering or a related technical/science filed encompassing biotechnology. * Ability to lead a team (either direct reports or indirect stakeholders) and develop employees * Detailed Knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry is required. * Technical experience with process scale-up, bioreactors, column chromatography and packing, UF/DF, filtration technologies and single-use systems all desirable. * Knowledge of E/F/U validation including cleaning strategies and CIP/SIP. * Experience with start-ups and new product introduction to commercial facilities is preferred. * Good problem solving skills and use of tools like FMEA, 5 Why’s with the ability to work under pressure and deliver on tight timelines. * Team player, highly self-motivated and able to work under minimum supervision. * Good command in oral and technical writing in English, and excellent communication and presentation skills.
Job Classification: Experienced
Primary Location: Singapore-Central Singapore-Singapore
Req ID: 1703221