Lead, Critical Utilities Engineering応募後で応募 求人ID R0021184 掲載日 07/17/2020 Location:Lexington, Massachusetts; Zurich, Switzerland
Here, you will be a vital contributor to our inspiring, bold mission.
As the Global Lead for Critical Utilities Engineering you will have the following objectives:
- Responsible and accountable for the development and implementation of engineering standards and programs for Critical GMP Utility Systems such as Water & Steam Systems (Water for Injection (WFI), Purified Water (PW), Clean Steam); Specialty Gases, Heating Ventilation Air Conditioning (HVAC) and Process Compressed Air/Vacuum, in addition to Black Utilities such as Plant Steam, Boilers, Pipe Racks, Bio-Waste System, Water Softeners, Industrial Waste Treatment System, Emergency Generators, Uninterruptible Power Supplies (UPS) to achieve world class manufacturing facilities with minimum environmental footprint
- Responsible for the implementation and management of a life cycle analysis approach in driving sustainable engineering solutions within the critical utilities space and collaborate with sites, regions and operations units engineering team to bring solutions to the manufacturing sites; all while ensuring Takeda’s environmental/sustainability commitments are met
- Technical authority in critical GMP utility systems providing support to technical and quality events as necessary (supporting investigations and audits) and responsible for establishing a critical utilities community/network at Takeda leading to harmonizing engineering technologies across manufacturing sites and ensure sharing and application of best practices and expertise.
- Engage key internal and external stakeholders and collaborate on new technology designs and implementation programs for critical utilities; partnering with FEED (Front End Engineering Design) teams, Operating Units, Regions and Site Engineering to support and deliver capital programs
- Provides global leadership and is responsible for the development and support of engineering standards for Critical Utility Systems and innovation solutions in engineering and manufacturing network for critical utilities
- Is aligned and works closely with the Life Cycle Asset & Maintenance Program (LAMP) to leverage a continuous improvement model to ensure fit for purpose preventive maintenance programs and metrics, including PM’s, WO’s, and calibration of all Clean Utilities equipment and instruments that delvers highly efficient and reliable operations.
- Develop standards and guidelines that support energy, sustainability and lifecycle management strategies in clean and black utilities systems
- Lead, coordinate and develop engineering implementation and execution road map for new critical utilities technology introduction
- Lead and establish critical utilities community of practice (CoP) leading to harmonize engineering technologies across manufacturing sites and ensure sharing and application of best practices and expertise.
- Technical support to CAPEX investment projects and investment applications
- SME for quality and technical related events relating to GMP Utility Systems and participates in investigation or audit support as necessary
- Owner of GE guidelines & templates for specific responsibilities of technologies
- Technology scouting at international conferences and events and SME to provide comments to global international standards or guidance documents (ISPE, ISO, etc)
- Technology team participation in concept design / scope-definition (feasibilities, feed /value Eng., vendor audits & selection) for critical cGMP aspects
- Liaising with ISIT, Innovation, Procurement and all other stakeholders involved in the development of existing and future technology solutions
DIMENSIONS AND ASPECTS
- A subject matter expert in critical utilities with hands on working knowledge and experience with facilities equipment and critical utility systems – Clean Steam, WFI, PW, and Process Compressed/Vacuum Air, in addition to Black Utilities such as Plant Steam, Boilers, Pipe Racks, Bio-Waste System, Water Softeners, Industrial Waste Systems.
- In-depth regulatory, quality and engineering expertise and experience in bio-pharmaceutical manufacturing environments.
- Knowledge of GMPs, FDA/EMA guidelines, and process validation
- Technical expertise for engineering disciplines in support of Operating Units including external partners / Sites / Projects and other functions outside of GMS (e.g., R&D)
- Incumbent thinks more broadly and uses this insight to challenge, adapt or transform current approaches/ways of doing things.
- Able to provide strategic direction and road map to evaluate, test/pilot, recommend and implement key areas of technologies collaborating with internal and external stakeholders
- Excellent stakeholder, communication and change management skills
- Strong focus on delivering results with a service excellence, dependability first mindset and collaboration skills
- Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
- Partner with key stakeholders to develop robust business cases and leads validation of benefits realization
- Work collaboratively with multiple stakeholders to recommend key technology solutions to ELT/GMS Leadership
- Provides technology expertise and accountable for successful implementation and execution plans
- Global / enterprise outlook bringing in trends and developments in critical utilities for proper evaluation
- Experienced in working in an intercultural; global, regional and site teams
- GMS Eng Leadership and GMS Leaders
- Site/OpU/Region Engineering Center of Practice (CoP) forums and teams
- Other functional leaders and engineering teams in Regions and OpUs
- Interacts with organizations outside of Takeda to understand industry trends and best technology and practices and adopts recommended technology that supports Takeda Transformation to a leader in bio-pharmaceuticals. Influence external organizations and serve as an Engineering Technology ambassador for Takeda
- Respected industry SME (internal or external) for areas of engineering and critical utilities
- Leads conversation in industry trends across industry peers and presents at industry forums (e.g., ISPE, PDA, etc)
- Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- Technical knowledge of Plasma Derived, Biologics and Small Molecule facility, engineering and manufacturing process highly desired
- Global regulatory and quality experience in design, development and implementation of new engineering solutions and technology – able to navigate regulatory challenges and familiar with global requirements
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Technical, Scientific and/or Engineering degree with 15 years of technical experience or an advanced degree in a scientific/technical discipline with 10 years of experience in biopharmaceutical engineering or similar industry
- Experience in Engineering Technologies supporting product development and/or manufacturing (both highly preferred).
- Recognized as an expert or leader in the critical utilities field.
- Experience in global process and facility engineering and the associated regulatory and quality requirements.
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
- Strong technical, interpersonal, communication and leadership skills.
- Knowledge of techniques utilized in the pharmaceutical sciences.
- Strong organizational and strategic thinking skills, required.
- Recognized externally as an expert (e.g., leads industry forums or invited speaker at conferences)
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. Discover more at takedajobs.com.
What Takeda Can Offer You
To further support and inspire our employees, our benefits include: Competitive basic salary, Car Allowance, Annual Bonus, Contributory Pension Scheme, Private Health Cover and Life Assurance.
Empowering Our People to Shine
Learn more at takedajobs.com