Validation Sr. Engineer

hace 6 meses


Heredia, Costa Rica ABBVIE A tiempo completo

Manage all departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.Manage all equipment, facility, utility and cleaning validation activities. Maintain the Validation Master Plan (VMP) as appropriate. Responsible for Validation Change Control documentation and managing the electronic tracking system.
- Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives.
- Interface with area managers from the Operations and Quality functions through the Validation Review Boards.Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
- Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.Manage validation related, quality improvement projects to foster R&D compliance to regulatory, corporate and department requirements.
- Represent department in quality audits, both internal and external, in regards to validation and engineering compliance.
- Cultivate and foster strong working relationships with packaging operations and engineering validation disciplines.
- Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
- Supervise FTE engineering technicians and contract validation engineering as needed. Ensure employee resource allotment and workload requirements are balanced to meet the forecasted needs of the business.
- Partners with all levels of key business functions to ensure packaging equipment has the functionality and is equipped to support new and ongoing clinical studies. Responsible for ensuring equipment reliability expectations are achieved in a high-throughput, clinical packaging facility.
- Continually evaluates and balances short term production support needs with long term strategic objectives of the department.
- Bachelor’s Degree, a BS in an engineering discipline.
- 5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
- Knowledge/experience in creating and executing validation documents in VMS.
- Knowledge/experience in Abbvie engineering and financial systems.
- General understanding of Abbvie Engineering Standards and Specifications.
- General understanding of pharmaceutical packaging equipment
- Software validation experience and data integrity requirements
- Horario de Lunes a Viernes de 8:00 am a 5:00 pm



  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, CR**Additional Locations**: Costa Rica-Heredia**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...

  • Engineer Sr, Process

    hace 6 meses


    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Heredia, 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...


  • Heredia, Costa Rica SGF Global A tiempo completo

    **Sr DevOps Engineer/ Cloud (Hybrid)** **Heredia, Costa Rica** SGF Global is looking for a Sr DevOps Engineer/ Cloud, for IT enterprise in Heredia, Costa Rica. **Requirements**: - Bachelors in Computer Science or equivalent work experience - 4-6 years of experience - Advanced Linux yum/dnf RedHat rpm package manager hands-on experience with solving...


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, 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...


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, 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...


  • Heredia, Costa Rica SGF Global A tiempo completo

    **Sr-Level Okta CIAM Developer** **Heredia, Costa Rica** SGF Global is looking for a Sr-Level Okta CIAM Developer, for IT enterprise in Heredia, Costa Rica. **Overview**: Sr-Level Okta CIAM Developer will be responsible for designing, implementing, and maintaining Okta Identity and Access Management (IAM) solutions to support our organization's CIAM...


  • Heredia, Costa Rica SGF Global A tiempo completo

    **Sr-Level Okta CIAM Developer (Remote)** **Heredia, Costa Rica** SGF Global is looking for a Sr-Level Okta CIAM Developer, for IT enterprise in Heredia, Costa Rica. **Overview**: Sr-Level Okta CIAM Developer will be responsible for designing, implementing, and maintaining Okta Identity and Access Management (IAM) solutions to support our organization's...


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Additional Location(s)**: Costa Rica-Heredia**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...


  • Heredia, Costa Rica Smarsh A tiempo completo

    **Who are we?** Smarsh empowers its customers to manage risk and unleash intelligence in their digital communications. Our growing community of over 6500 organizations in regulated industries counts on Smarsh every day to help them spot compliance, legal or reputational risks in 80+ communication channels before those risks become regulatory fines or...


  • Heredia, Costa Rica Smarsh A tiempo completo

    **Who are we?** Smarsh empowers its customers to manage risk and unleash intelligence in their digital communications. Our growing community of over 6500 organizations in regulated industries counts on Smarsh every day to help them spot compliance, legal or reputational risks in 80+ communication channels before those risks become regulatory fines or...

  • Quality Engineer Iii

    hace 7 meses


    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Quality Engineer (Process, Systems and Supplier) **Department**: Quality Assurance **Document Purpose**: this document serves as guidance to establish the professional classification in the quality engineering area, defining specific and general activities that require revision on each position to establish the correct scope and...


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**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...


  • Heredia, Costa Rica Viant Medical A tiempo completo

    Responsibilities - Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations,...


  • Heredia, Costa Rica Viant Medical A tiempo completo

    **Main Purpose of Job**: Under the direction of Manufacturing / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, documents handling, BOMs creation,...


  • Heredia, Costa Rica Viant Medical A tiempo completo

    **Main Purpose of Job**: Under the direction of Manufacturing / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, documents handling, BOMs creation,...


  • Heredia, Costa Rica Viant Medical A tiempo completo

    Responsibilities - Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations,...


  • Heredia, Costa Rica Smarsh A tiempo completo

    Smarsh seeks a **Sr. Technical Support Engineer** to provide high touch support to our biggest and best customers. **What will you do?**: - Provide frontline support role for Enterprise products or Backline support role for Saas-hosted solutions or Enterprise products. Works on assignments that are complex in nature where independent action and high degree...


  • Heredia, Costa Rica NTT DATA A tiempo completo

    **Req ID**: 269124 We are currently seeking a Sr-Level Okta CIAM Developer to join our team in Heredia, Heredia (CR-H), Costa Rica (CR). We are looking for a Sr-Level Okta CIAM Developer to join our team. In this role, you will be responsible for designing, implementing, and maintaining Okta Identity and Access Management (IAM) solutions to support our...


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**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...

  • R&d Engineer Sr

    hace 6 meses


    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Heredia, CR**Additional Locations**: Costa Rica-Heredia**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...