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AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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1901979 Requisition #
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  • Report to the Engineering Technical Support Manager, as part of the Engineering Organization in AbbVie Operations Singapore

  • As the Subject Matter Expert (SME) in technical and Qualification topics related to GMP E/F/U systems, provide guidance and support to establish systems for ensuring compliance to validated status of E/F/U systems

  • Establish validation master plans and validation execution plans for GMP Equipment, Facilities and Utilities (E/F/U) in the AbbVie Operations Campus in Tuas, Singapore comprising of both API and Biologics manufacturing facilities

  • Generate, review and execute protocols for initial and subsequent re-qualification programs related to E/F/U systems

  • Work with teams that provide Quality Assurance oversight to ensure compliance to cGMP standards and AbbVie policies and procedures

  • Collaborate with validation and tech support teams in other sites within the AbbVie network to

  • ensure a harmonized approach to qualification of E/F/U systems

  • Remain abreast of continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems and contribute to the implementation of plans to address any gaps

  • Provide support to Operations & Maintenance (O&M) personnel on issues that potentially impact validated status of the E/F/U systems

  • To provide support., as needed, to ongoing projects and plant operations on a 24 x 7 basis and ensure total compliance to cGMP and safety standards

  • Develop monitoring and control regimes and play a key role in improving compliance KPIs

  • Supervise contractors, engineers and technicians and provide day to day support to operations including, modifications and changes to processes and equipment, troubleshooting, deviation investigation, identification and completion of corrective and preventative actions

  • Maintain records to comply with Good Manufacturing Practice requirements

  • Assist in the review and assessment of Change Requests and responses to CAPAs

  • To actively assist in recruitment, nurturing and retention of employees to support ongoing and future business needs of Abbvie Singapore

  • Actively engaged in developing specifications for equipment and utility systems and assist in FAT / SAT of related equipment as part of the new build-outs

  • Any other duties as assigned by your Supervisor/Manager

  • Bachelor’s degree or a diploma of technical specialization like Engineering/Pharmacy

  • At least 8 years of relevant work experience

  • Hands-on experience in Commissioning & Qualification of start-ups and brownfield projects essential

  • Excellent leadership and communication skills

  • Ability to lead teams including external contractors

  • Mentoring and coaching skills

  • Excellent team player willing to work for the common goal

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