Validation Engineer II Temporary

Título del trabajo: Validation Engineer II Temporary

Compañía: Terumo BCT

Descripción de funciones: Job summary:Responsible for supporting, revising and overseeing the execution of, and validation procedures/protocols to ensure that there is sufficient documentation to support the regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.Essential duties:

• Lead validation projects related to authoring and executing specifications and validation documentation according to the Validation Life Cycle. (URS, FRS, DS, IQ, OQ, PQ), and reports.
• Support risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Validation Plan.
• Develops solutions to problems that are unusual and complex that affect diverse functional areas of the company.
• Bring together multiple concepts across job areas to define a new direction or a significant advance to products and services.
• Interprets, executes, and recommends modifications to operating policies on a multifunctional basis.
• Reviews, implements, and enforces related SOPs.
• Primary lead on validation efforts and manages the coordination of intra and inter-company projects.
• Enforces and influences internally and externally on matters pertaining to policies, plans, projects, and objectives.

Education:

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

Licenses or certifications:

• N/A.

Experience:

• Minimum 3 years’ experience in validation process.

Job summary:Responsible for supporting, revising and overseeing the execution of, and validation procedures/protocols to ensure that there is sufficient documentation to support the regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.Essential duties:

• Lead validation projects related to authoring and executing specifications and validation documentation according to the Validation Life Cycle. (URS, FRS, DS, IQ, OQ, PQ), and reports.
• Support risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Validation Plan.
• Develops solutions to problems that are unusual and complex that affect diverse functional areas of the company.
• Bring together multiple concepts across job areas to define a new direction or a significant advance to products and services.
• Interprets, executes, and recommends modifications to operating policies on a multifunctional basis.
• Reviews, implements, and enforces related SOPs.
• Primary lead on validation efforts and manages the coordination of intra and inter-company projects.
• Enforces and influences internally and externally on matters pertaining to policies, plans, projects, and objectives.

Education:

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

Licenses or certifications:

• N/A.

Experience:

• Minimum 3 years’ experience in validation process.

Job summary:Responsible for supporting, revising and overseeing the execution of, and validation procedures/protocols to ensure that there is sufficient documentation to support the regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.Essential duties:

• Lead validation projects related to authoring and executing specifications and validation documentation according to the Validation Life Cycle. (URS, FRS, DS, IQ, OQ, PQ), and reports.
• Support risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Validation Plan.
• Develops solutions to problems that are unusual and complex that affect diverse functional areas of the company.
• Bring together multiple concepts across job areas to define a new direction or a significant advance to products and services.
• Interprets, executes, and recommends modifications to operating policies on a multifunctional basis.
• Reviews, implements, and enforces related SOPs.
• Primary lead on validation efforts and manages the coordination of intra and inter-company projects.
• Enforces and influences internally and externally on matters pertaining to policies, plans, projects, and objectives.

Education:

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

Licenses or certifications:

• N/A.

Experience:

• Minimum 3 years’ experience in validation process.

Ubicación: Cartago

Fecha del trabajo: Fri, 08 Nov 2024 00:49:32 GMT


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