AbbVie Senior / Technical Operations Engineer in Jurong, Singapore
Senior / Technical Operations Engineer
Singapore, South West, Jurong
Manufacturing & Operations
Requisition # 1907189
Responsible for manufacturing support of late stage biologics processes. Subject matter expert for cell culture and/or purification process unit operations and equipment. Provides rapid response to operational issues and supports ongoing operations including new product introduction, process optimization, monitoring and cleaning. Provides leadership, training and coaching of manufacturing personnel.
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
Any other duties as assigned by supervisor
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 Type: Experienced
Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.