Global Biologics Expert

2 weeks ago

Dundalk, Louth, Ireland beBeeBiologics Full time €94,280 - €143,160
Senior Global Biologics Expert

We are seeking a seasoned professional to join our team in accelerating and transforming biologics discovery, development, and manufacturing.

  • The successful candidate will oversee project lifecycles, manage automation systems, integrate Vendor VPEs, oversee Building Management System (BMS), and implement OT applications.
  • They will draft documents, conduct design reviews, perform acceptance testing, and ensure qualifications align with GAMP5 standards.
  • The ideal candidate will ensure seamless integration of automation workstreams at the site by driving functional commitment on projects.
  • They will also manage project finances, forecasts, risks, change processes, and provide regular status reports.
  • The Senior Global Biologics Expert will facilitate productive project meetings, lead steering discussions, and actively encourage risk and problem management.
  • They will coordinate system handover planning and provide post-project support to on-site engineering and maintenance teams.
  • The position requires identifying opportunities for continuous improvement and collaborating on joint programs with key stakeholders.
Required Skills and Qualifications
  • Bachelor's degree in relevant fields with a minimum of 10 years of experience in the pharmaceutical/biological industry.
  • Familiarity with biologics drug manufacturing processes and key process equipment.
  • Experience in projects involving system integration, automation, instrumentation, controls, or manufacturing digitalization in the pharmaceutical/biochemical/biological industry.
  • A track record of leading complex projects and cross-functional initiatives.
  • Familiarity with major DCS and working knowledge of BMS/SCADA/PLC systems.
  • Strong customer service, coordination, and interpersonal skills.
  • Good knowledge of GMP regulations.
  • The ability to work across regions, time zones, and travel domestically and internationally.
Key Responsibilities

The Senior Global Biologics Expert will be responsible for:

  • Collaborating with technical teams and key stakeholders to collect user requirements and present innovative technical solutions.
  • Drafting documents, conducting design reviews, performing acceptance testing, and ensuring qualifications align with GAMP5 standards.
  • Managing project finances, forecasts, risks, change processes, and providing regular status reports.
  • Ensuring seamless integration of automation workstreams at the site by driving functional commitment on projects.

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