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Senior Project Engineer II - Process

Company: Takeda Pharmaceuticals International GmbH
Location: Lexington
Posted on: April 9, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Every day, employees working in Takeda's Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients. Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference. Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Job ID R0034336 Date posted 04/02/2021 Location Lexington, Massachusetts By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Project Engineer II - Process in our Lexington, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Position Overview: The candidate will be responsible for technical leadership of equipment, automation and / or facility improvement projects within operating commercial manufacturing facilities and primarily focus on technical deliverables around feasibility/conceptual development, basic design, detailed design and implementation. The candidate will be accountable for robust and timely delivery of project engineering deliverables in a cross-functional environment.

Position requires technical expertise in bioprocess equipment, process piping design, control systems, or plant utility systems. Experience with upstream and downstream biopharmaceutical facility design, comprehensive knowledge of Good Engineering Practices (GEP) and familiarity with ASME BPE, ASTM E2500 methodology is preferred. Candidate will be a key technical interface between Manufacturing and Facility clients, Engineering SMEs, and external engineering / vendor resources during feasibility, conceptual design, detailed design, specification, procurement, construction / fabrication, and commissioning / verification of process and utility equipment for cGMP production facilities.

All system improvements will be made in conjunction with Manufacturing, Facilities & Engineering Manufacturing Sciences, Quality Assurance, Validation, and Regulatory functions. Candidate will be asked to develop and present practical solutions to a variety of complex problems which require the regular use of ingenuity and innovation.
Responsibilities Job Function and Description 30% Origination and Conceptual Development

  • Generates and develops technical project scope
  • Documents all process/product, general user requirements and generates basis of design packages
  • Uses ingenuity and creative thinking to develop solutions
  • Supports project managers in development of next-phase design and / or implementation plans 30% Basic design, detailed design, and planning
    • Develops schematic and detailed design of systems including construction documents (P&IDs, layouts, etc.)
    • Specifies and sizes process, utility, and / or automation equipment
    • Plans, coordinates, and drives design, design review, and peer review activities
    • Manages external project engineering services effectively
    • Leads design reviews and risk assessments to identify critical aspects and verification methods Ensures development of FAT, commissioning & verification plans 15% Implementation and close out
      • Reviews and approves submittals
      • Ensures successful FAT, SAT, commissioning, and verification execution and approval
      • Ensures completion and turnover of all project origination design development, and ETOP documentation.
      • Supports final robustness and fitness for use checks 25% Standards, templates, and procedures
        • Develop project engineering procedures, guidelines, and tools to help achieve consistency
        • Evaluates Shire's practices against best practices and identifies program improvements
        • Creates URS/FRS/DDS templates for use across sites
        • Develops standardized commissioning and verification templates Education and Experience Requirements Required education: Bachelors degree in Chemical or Mechanical Engineering.
          • Minimum 8 years experience in a cGMP Engineering environment
          • Minimum 5+ years experience in equipment design and oversight of fabrication
          • Knowledge of Quality by Design (QbD), Quality Risk Management (QRM) based on ICH Q8, Q9, and Q10 guidelines and experience with implementing systems following the ASTM E2500 framework is desirable. Key Skills, Abilities, and Competencies
            • Must be able to work without appreciable direction to plan, coordinate, and ensure completion of engineering team deliverables
            • Effective verbal and written communication skills
            • Excellent interpersonal, teamwork, and leadership skills required
            • Exercises considerable latitude in determining objectives and approaches to assignments and plans, schedules and arranges own activities in accomplishing milestone achievements
            • Ability to multi task in a dynamic environment with changing priorities
            • Proficiency with Microsoft Products; ability to learn additional software applications as the need arises Complexity and Problem Solving
              • Individual must be capable of performing assignments to develop solutions to complex problems which require the regular use of ingenuity and innovation and where analysis of situations or data requires an in-depth evaluation of variable factors.
              • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.--
              • Ensures solutions are consistent with organization objectives and serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.
              • Contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.
              • Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
              • Assists management in training and coaching less experienced project engineering staff Internal and External Contacts
                • Individual will represent Project Engineering and to work closely with Project Managers, Schedulers, Engineering SMEs, Manufacturing, Facility, Supply Chain, and QC clients, Validation , Quality, Procurement, Engineering Documentation Control and HS&E team members.
                • The candidate must be able to integrate the Validation and Quality department requirements into all project phases
                • Networks with key contacts outside own area of expertise as well as senior internal contacts within area of expertise.
                • Manages external project engineering service providers Check out where you could be
                  working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Huntsville , Senior Project Engineer II - Process, Engineering , Lexington, Alabama

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