Process Validation Manager

Job summary
This position would report to 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
• 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
• Bachelor of Science in Engineering or other technical field required.
• Minimum 8 years experience in the medical device industry or GMP manufacturing preffered
• 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.

- Additional Health Care
- Laptop & Hand phone provided
- Transportation provided from HCMC and Bien Hoa

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