Technology & Innovation Lead, Process Equipment DP (f/m/d)

3390 Baxalta U.S.Lexington, MA
Onsite

About The Position

Champion the transformation of process and manufacturing technologies for Takeda’s Drug Product (DP) network by setting technical direction, building technology visions and strategies, and enabling scalable execution. Provide specialist process, plant and reliability engineering expertise to ensure safe, environmentally sustainable, reliable, cost-effective, and scalable technical solutions for DP manufacturing plants. Translate site and network needs into harmonized best practices, standards, and roadmaps, ensuring solutions meet Regulatory, Quality, Capacity, and EHS requirements. Accelerate innovation by combining industry benchmarking/scouting with structured deployment approaches aligned to modern digitalization/Pharma 4.0 expectations (data-driven decisions, connectivity, security, and maturity).

Requirements

  • Technical, scientific and/or engineering degree with 10-15 years of technical experience in biopharmaceutical / pharmaceutical engineering or similar industry.
  • Proven knowledge in Engineering technologies supporting product development and/or manufacturing, ideally in Drug Product manufacturing equipment (e.g., Formulation, Fill & Finish, Inspection, Packaging).
  • Strong technical, interpersonal, communication and leadership skills.
  • Recognized as an expert and leader in their specific field (e.g., leads industry forums or invited speaker at conferences).
  • English fluency (Written/Oral).
  • Proven capability of acquiring knowledge and applying problem-solving methodologies.

Nice To Haves

  • Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
  • Knowledge of industry 4.0 technology.

Responsibilities

  • Lead, coordinate, and develop technology visions, strategies, and execution roadmaps for DP equipment technologies to accelerate innovation programs and improve network performance.
  • Provide inputs for and/or own parts of the innovation roadmap for process engineering strategies; ensure DP technology choices are benchmarked against peers and best-known methods.
  • Actively scout technology and participate in industry conferences/forums to identify emerging solutions and translate them into deployable, value-based initiatives.
  • Drive DP technology strategies that leverage digitalization for faster decision-making and improved control over operations, quality, and compliance - recognizing increased connectedness.
  • Drive awareness of advanced manufacturing expectations and evolving global guidance as relevant to DP equipment strategies and future platform decisions.
  • Lead DP process engineering contributions by defining technical strategies and providing critical DP manufacturing support across multiple sites (matrix).
  • Lead evaluation of existing processes/equipment and define improvements to yield, efficiency, robustness and operability while maintaining acceptable quality.
  • Establish/lead technology groups and Communities of Practice (CoPs) to harmonize engineering technologies across sites and ensure sharing and application of best practices and expertise.
  • Own/author standards, guidelines, templates for DP process equipment technologies; drive consistent interpretation and application across the network.
  • Establish sustained, collaborative communication with the process engineering community to understand site needs, installed standards, rationales, and local constraints.
  • Develop & nurture core competencies of site SMEs to build enduring technical capability and knowledge continuity.
  • Provide technical SME support to CAPEX investment projects, Design Engineering function, and investment applications, including support to feasibility studies, FEED, scope definition, value engineering, and vendor audits/selection - particularly for critical cGMP aspects and innovation.
  • Lead evaluation of equipment design selection criteria supporting network strategy, capital investments, lifecycle management, and tech transfer - balancing efficiency, capacity, safety, sustainability, standards, and regulatory requirements.
  • Liaise with key internal stakeholders involved in development and deployment of current and future solutions (Global Engineering, sites, leadership teams, and cross-functional partners).

Benefits

  • We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
  • For information about our benefits, please click here.
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