Validation Engineer

hace 2 semanas

Cartago, Costa Rica Tekni-Plex A tiempo completo

**SUMMARY**:
The Validation Engineer will be responsible for performing and overseeing the validation of manufacturing processes. Support the quality assurance of all activities within the process, ensuring that all systems are running according to the specifications and operations standards monitoring budget, and controlling purchase and documentation

**ESSENTIAL DUTIES AND RESPONSIBILITIES**
- Lead/ support/conduct IQ, OQ, PQ validation studies of equipment and processes validations.
- Select and utilize a wide range of appropriate statistical methodologies and techniques.
- Give advice to project teams, develop/review and approve validation protocols and final reports.
- Assist with/conduct validation studies.
- Design process characterization studies, conduct statistical analysis of results using Minitab or equivalent to identify critical parameters and improve process capability.
- Generate and resolve protocol discrepancies or deviations.
- Continually improve the Quality System Validation program.
- Participate in project planning, scheduling, and tracking.
- Develop and implement procedures to comply with corporate and industry standards.
- Organize and archive validation documentation.
- Provide validation training to Operations employees.
- Mentor support, validation and staff engineers.
- Support the response to customer quality concerns, following six-sigma methodology to determine root cause of problems and implementing sound corrective actions.
- Perform gap analysis on previously performed validation/qualifications and if required, design and implement protocols to mitigate deficiencies in previous validation/qualifications.
- Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer’s specifications, operational procedures, calibration requirements and required maintenance.
- Review equipment calibration and maintenance documentation and ensure Facilities is performing required calibration and maintenance in accordance with preset schedules.
- Ensure change control procedures are being followed with respect to facility, equipment and utility changes and provide adequate oversight and follow-up on validation deviations both in terms of content (root cause) and in terms of CAPA.
- Perform periodic assessment of validation/qualification procedures and policies. Write and edit validation/qualification protocols and SOPs.
- Responsible for providing validation/qualification trending data to management.
- Assist with client and QA audits by explaining validation and qualification activities performed at the site.
- Support process improvement initiatives in Manufacturing Engineering (OPEX)
- Other duties as assigned.

**QUALIFICATIONS**:
**EDUCATION and/or EXPERIENCE**:

- A Bachelor’s degree in a related engineering field such as Mechanical, Electrical, Industrial, Chemical or Material Science is required with 2+ years in Quality/Validation in Medical Device Industry Engineering roles working with validation, qualification of equipment experience or equivalent combination of education and experience.
- Knowledgeable in computer programs including Microsoft Word and Excel.
- Ability to learn how equipment functions and then design appropriate validation/qualification protocols.
- Experience with Statistical Process Control methods (control charts, Cpk’s etc.)
- Knowledge of good manufacturing practices (GMP’s) encompassing plastics extrusion lines, and calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.
- Proficient in GD&T and metrology. Ability to read and interpret prints and tool designs.
- Ability to troubleshoot solve problems independently or as part of a team.
- Excellent verbal and written English (B2) communication skills - Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans.
- Knowledge of Six Sigma is required and certification is a plus.

**LANGUAGE SKILLS**:

- Communicates well orally and can edit documents with proper grammar and sentence structure.
- Ability to write technical correspondence in English and Spanish.
- Ability to effectively present information one-on-one and small group situations to customers, clients and other employees of the organization.

Pay: ₡22,000.00 - ₡32,000.00 per year

Ability to commute/relocate:

- Cartago, Provincia de Cartago: Reliably commute or planning to relocate before starting work (required)

**Language**:

- English (preferred)

  • Validation Engineer

    hace 3 semanas

    Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaJob function summaryThe Validation Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure compliance...

  • Validation Engineer

    hace 4 días

    Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Ubicación**: Cartago, Costa Rica, CR **Familia de puestos**: Control de Calidad **País**: Costa Rica Job function summary The Validation Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure...

  • Software Validation Engineer

    hace 4 semanas

    Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaSoftware Validation Engineer, Coloplast CartagoAre you motivated by quality control of medical device products with the purpose of improving the lives of people with intimate health care needs?We are looking for a dedicated Software Validation Engineer to...

  • Validation Engineer

    hace 6 días

    Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Location**: Cartago, Costa Rica, CR **Job Family**: Quality Assurance **Country/Region**: Costa Rica Job function summary The Validation Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure...

  • Validation Technician

    hace 6 días

    Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Location**: Cartago, Costa Rica, CR **Job Family**: Quality Assurance **Country/Region**: Costa Rica Job function summary The Validation Technician will work on the production floor to ensure compliance within process validation with external and internal requirements and ensure compliance to the quality management system. Major areas of...

  • Engineer Ii, Quality

    hace 3 semanas

    Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**:- Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Engineer Ii

    hace 3 semanas

    Cartago, Costa Rica Heraeus Holding Gmbh A tiempo completo

    **Process Development Engineer II****Summary**Hands-on engineer responsible for providing expertise in developing manufacturing processes for electrophysiology catheters, and similar products.Demonstrates competence in medical device and manufacturing environment.Support and own processes from development through production including process development,...

  • Sr Engineer Quality

    hace 5 días

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    **Key Responsibilities**: - Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, Edwards Lifesciences SOPs and Good Documentation Practices (GDP) Utilize test equipment to verify equipment parameters, process outputs or...

  • Engineer Ii, Quality Temporary Position 12 Months

    hace 6 días

    Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality temporary position 12 months**: - Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...

  • Process Development Engineer

    hace 6 días

    Cartago, Costa Rica Nextern A tiempo completo

    **SUMMARY** A process development engineer plans, designs and executes cost-effective production systems, in order to enhance the speed and quality of processing, and ensure produced items comply with international regulations and industry standards. Process development engineers use technical knowledge and industry expertise to review existing...

  • Engineer Ii

    hace 3 días

    Provincia de Cartago, Costa Rica Heraeus Holding GmbH A tiempo completo

    **Process Development Engineer II** **Summary** Hands-on engineer responsible for providing expertise in developing manufacturing processes for electrophysiology catheters, and similar products. Demonstrates competence in medical device and manufacturing environment. Support and own processes from development through production including process...

  • Production Engineer

    hace 3 semanas

    Cartago, Costa Rica Rau Precision Metals S.A. A tiempo completo

    ACERCA DE LA VACANTEFunciones del Puesto- Planning and controlling work on the shop floor.- Determine and assure quality standards.- Preparation and controlling machines and tools.- Supervising work in the shop.- Training and instruction of workers.- Control and follow-up used production times of closed working steps and orders.- Manage of human and material...

  • Automation & Validation Engineer Ii

    hace 3 semanas

    Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Drive the design, integration and implementation of global GSC manufacturing Process Control Network and automation systems throughout the production plant.**Key Responsibilities**:Digitize and automate portions of the manufacturing process and equipment, at the Edwards manufacturing facilities within project team, while focusing on process efficiency and...

  • Sr Microbiology Engineer

    hace 3 semanas

    Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Cartago, CR**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health.That is...

  • Sr, Quality Engineer Cartago

    hace 4 semanas

    Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and...

  • Engineer Ii, Quality Sys

    hace 3 semanas

    Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality Sys**:- Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Process Technician

    hace 3 semanas

    Cartago, Costa Rica Grupo Preseleccion Ely S.A. A tiempo completo

    Support to plans and directs major engineering projects of a complex nature.Applies intensive and diversified knowledge of engineering principles and practices in broad areas of manual assembly process.Plans, schedules, and coordinates detailed phases of the engineering work in a part of a major project or in a total project according to the regulations and...

  • Validation Engineer Ii

    hace 7 días

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...

  • Process Engineer

    hace 2 días

    Cartago, Costa Rica GRUPO PRESELECCION ELY S.A. A tiempo completo

    **Responsabilities**: Lead both SMT and FSS (Fountain Selective Solder) Production resources at Lutron’s new manufacturing facility. Drive the installation and validation of new equipment. Institutionalize SMT and FSS processes within the facility. Find root causes to quality issues and drive their resolutions. Own the facility metrics of Efficiency, CPH,...

  • Process Engineer

    hace 4 semanas

    Cartago, Costa Rica Grupo Preseleccion Ely S.A. A tiempo completo

    **Responsabilities**: Lead both SMT and FSS (Fountain Selective Solder) Production resources at Lutron's new manufacturing facility.Drive the installation and validation of new equipment.Institutionalize SMT and FSS processes within the facility.Find root causes to quality issues and drive their resolutions.Own the facility metrics of Efficiency, CPH,...