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AbbVie Senior / Technical Operations Engineer in Jurong, Singapore

Senior / Technical Operations Engineer

Singapore, South West, Jurong

New

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.

Major Responsibilities:

  • 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

Additional Information

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time

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.

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