Senior Engineer. Quality Validation

JOB SUMMARY

This position will be part of the Quality validation team in Vietnam. This position requires independent evaluation,

selection and application of standard engineering methods and practices, using judgment and ingenuity.

Responsibilities include but are not limited to writing process validation plans, protocols, reports and being

involved in the development and improvement of manufacturing processes. This position may be responsible for

completing process requirements documentation, understanding the architecture and validation strategy for non-

product software, writing, and executing test method validations, and maintaining the validation master plan. A

thorough understanding of the process validation lifecycle is required for this position.

ESSENTIAL DUTIES

• Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing

equipment, facilities areas, and process utilities systems.

• Manages projects including development of project scope and estimates, initiation of requests for capital

when required, specification of equipment and installation requirements, management of costs to budget,

initiates Equipment qualification, Process Qualification, Software validation, Test Method validation and

requalification documentation in accordance with acceptable engineering practices.

• Receives assigned total project leadership responsibilities on a portion of major significant projects and

will be given total management responsibility for smaller projects.

• Manages and provides leadership for the functional group’s development, direction, and effectiveness,

adhering to organizational policies and processes and supporting overall business and corporate

objectives.

• Implements and understands FDA or regulatory requirements as necessary.

• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related

technical areas.

• Advises team members pro-actively on technical ideas and promotes skill development of teamwork.

• Interacts with peers across projects to secure resources and commitments.

• Handles frequent inter-organizational and outside customer contacts. Represents the organization in

providing solutions to difficult technical issues associated with specific projects.

• Follows technical specification requirements and provides feedback on various technical processes and

procedures.

• Works cooperatively and effectively within a team environment to achieve common goals and results,

often influencing the outcome of the team(s).

• Propose improvement, change to processes and procedures and methods based upon data collection

and analysis by coordination with a cross-functional teams.

• Performs Risk management (ISO14971, ICH Q9,…) in validation strategy, sampling plan.

• Resolve deviation during the validation activities (Applying problem solving techniques (8D, 7 QC tools,…).

• Owner of NC/CAPA related to validation activities.

• Applies statistical methods in validation activities.

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

• Four-year Bachelor of Science in Engineering, preferred.

Experience

• Good understanding of validation life cycles approach for medical device and pharmaceutical industry.

• Minimum 4 years of experience in medical device or pharmaceutical manufacturing in Quality Assurance and/or Validation engineering.

Skills

• Fluency in English required.

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

• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.

• Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.

• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.

• Understanding of and adherence to GMP practices and FDA regulations.

• Knowledge and ability to implement FDA or regulatory requirements as necessary.

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

• Knowledge of relevant process control software applications.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.