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Validation Engineering Manager - Expat Vietnam

Date: Nov 30, 2018

Location: Ho Chi Minh City, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  12545  

 

                                                                            

Terumo BCT – Vietnam

Validation Engineering Manager

 

Background

Terumo BCT's newest manufacturing facility, TBV, located in Dong Nai Province, Vietnam, near Ho Chi Minh City, is rapidly growing and will soon become the largest manufacturing facility for Terumo BCT.  Within 6 - 12 months, TBV will be at full capacity, which is more than a 50% increase relative to the current production volumes.  In addition, Terumo BCT will be making significant investments in TBV over the next few years which will increase the manufacturing footprint by more than 50%.

TBV produces whole blood collection/processing disposable kits and Trima apheresis collection disposable kits for customers worldwide.  For more information, visit our web site at www.terumobct.com.

The unprecedented growth of the TBV factory presents many challenges for Operations, Engineering, Supply Chain & Logistics, Quality, and all departments. The expanding organization requires the addition of a Process Validation Engineering department.

 

Job Opportunity

This position would report to the Senior Manager of Process Validation and Supplier Engineering and partner with the Director of Process Engineering with the primary focus being the mentoring and developing of the engineers in the new department, providing guidance for:

·Process validation technical proficiency;

·Problem solving methods

·Development of key contacts within the organization;

·Cross-functional communications;

·Trouble-shooting techniques;

·Root cause analysis;

·Organizational Process Design;

·Change Control;

·Change Management;

·Alignment with Terumo BCT’s global objectives

·Working in a Global Team environment; and

·Communication skill development in a multi-language factory.

This position will reside in TBV with the expectation of a minimum, 2-year expat agreement.

This TBV position will partner closely with the Lakewood-based management and require periodic travel to the US and other locations.

 

Essential Duties

The successful candidate will have a track record of consistently exceeding expectations of an Engineering Manager, with some of the following skills and experience:

·Leads and is accountable for projects and drives results.

·Guides the successful completion of major programs, potentially in a project leadership role, where erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.

·Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.

·Develops new processes that have a significant impact on multiple disciplines. 

·Contributes to the establishment of business objectives, goals, budgets and costs as requested.

·Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively.

·Mentors less experienced engineers.

·Provides broad-based direction for subordinates and colleagues within functional area and cross functionally. 

·Applies technical expertise to complex tasks with in-depth knowledge of related work areas.   

·Employs in-depth knowledge of numerous technical areas and applies knowledge to other areas.

·Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.  

·Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

·Keeps updated on technical advances within the industry and applies this knowledge.

 

Additional Duties and Responsibilities

·Work direction responsibility may include technicians and junior engineers.

·Works with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

·May contribute to the establishment of business objectives, goals, budgets and costs.

 

 

Minimum Qualification Requirements

Education

·Bachelor of Science in Engineering or other technical field required.

Experience

·Minimum 8 years’ experience.

oFive years of experience in the medical device industry

oTwo years of GMP manufacturing experience.

oTwo years of leadership experience

Skills

·Requires demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology. 

·Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.

·Demonstrated project management skills in a global environment

·Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.

·Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.

·Knowledge and ability to implement FDA and other regulatory requirements as necessary. 

·Driver for acquiring resources and building consensus across products.

·Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.

·Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.

·Understanding of and adherence to GMP practices and external regulations.

·Demonstrated ability to communicate effectively both verbally and in writing. 

·Knowledge and use of relevant PC software applications and skills to use them effectively.

 

 

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


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