Mine Gulmen

Angestellt, Lead Engineer, No Deviation Pte Ltd
Singapore, Singapur

Fähigkeiten und Kenntnisse

GxP
Qualification of equipment
Qualification of utility systems
Pharmaceuticals
Quality Compliance
FDA Regulation
GAMP5
Commissioning of systems

Werdegang

Berufserfahrung von Mine Gulmen

  • Bis heute 9 Jahre und 8 Monate, seit Dez. 2015

    Lead Engineer

    No Deviation Pte Ltd

    Amgen Manufacturing Singapore (Mar 2022 – present) as Sr. CQV Engineer In-house project: ISO 9001:2015 Compliance (Feb 2022) MSD (Merck Sharp & Dohme) Singapore (Jan 2021 – Sep 2021) as Sr. Validation Engineer Novartis Singapore (Jun 2017 – Apr 2021) as Engineering Compliance Expert Abbvie Manufacturing Plant Project Singapore (Dec 2015 – May 2017) C&Q Engineer

  • 2 Jahre und 8 Monate, Apr. 2013 - Nov. 2015

    Validation Consultant

    CONVAL GROUP

    Designs and implements qualification activities of - Process equipment - Purified water systems - Compressed air systems - Building management systems (HVAC) - Quality management systems

  • 4 Monate, Juni 2011 - Sep. 2011

    Business Management Project Participant

    Trumpf Group

    Developed a “Lead Indicator Management” system for internal steering and external prognosis for the two main divisions of Trumpf, Machine Tools and Laser Technologies, as part of the international team of four Mannheim MBA participants.

  • 2 Jahre und 2 Monate, Okt. 2006 - Nov. 2008

    Product Manager

    Intendis (Bayer HealthCare)

    • Prepared annual brand plans in accordance with sales and EBIT targets • Analyzed market research data • Established up-to-date marketing strategies • Created initial versions of marketing aids by thorough scan of proof sources • Coordinated all associated medical marketing events • Made key customer visits • Trained new sales reps • Prepared P&L scenarios taking into account price changes and product life-cycle

  • 2 Jahre und 2 Monate, Juli 2004 - Aug. 2006

    Validation Engineer (Quality Assurance)

    Abdi Ibrahim Pharmaceuticals

    • Executed qualification of the Building Management System (HVAC) within a team of consultants, vendors and employees of validation, electrics and mechanics departments • In charge of performance qualification of HVAC, pressurized gas and water systems • Created system validation SOPs

Ausbildung von Mine Gulmen

  • 1 Jahr und 1 Monat, Sep. 2010 - Sep. 2011

    Management

    Mannheim Business School (in coop with Warwick Business School and EADA)

  • 2 Jahre und 6 Monate, Feb. 2001 - Juli 2003

    Chemical Engineering

    Bogazici University

    Molecular modelling and simulation, heterogeneous catalysis, CO oxidation, Pt-Sn catalysts

  • 3 Jahre und 11 Monate, Sep. 1996 - Juli 2000

    Chemical Engineering

    Bogazici University

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Gut

  • Türkisch

    Muttersprache

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