Validation Engineer III (Transfer & Sustaining)
Heredia - Costa Rica
Job Summary
Manage the operational strategy of the validations area ensuring that the equipment processes and systems in the plant remain properly qualified and validated in accordance with Allergans standards regulations and procedures as well as actively supporting business growth and continuous improvement.
MAJOR RESPONSIBILITIES
- Identify best practices in resource management that ensure low turnover resource maximization and suitable results that guide the companys operational success.
- Negotiate with customer areas and external representatives on priorities and tasks related to validation and associated studies safeguarding the companys key interests and participate in the evaluation of changes to validated processes.
- Coordinate with various areas the plants needs regarding equipment and process validation.
- Identify the competencies of area resources to assign tasks to direct reports ensuring outcomes and providing proper follow-up.
- Facilitate the execution of various tasks by providing administrative assistance focused training and specialized courses.
- Identify improvement opportunities and look after the professional and personal growth of assigned staff and participate in the development and implementation of new products and processes and actively identify and implement process improvements.
- Ensure compliance with corporate and legal EHS requirements and global policies (integrity/ethics adverse events etc.) by adhering to the applicable policies and internal procedures. Ensure compliance with regulatory standards.
- Participate in the evaluation of changes to validated processes and actively identify and implement process improvements.
- Ensure Data Integrity (DI) compliance with regulatory standards and Abbvies corporate procedure requirements.
- All other functions inherent to the position and those assigned by the immediate supervisor.
Qualifications :
EDUCATION
Bachelors or Associates degree in Electrical Electronic Electromechanical Engineering Biotechnology Chemistry or a related field.
EXPERIENCE
Five (5) to Six (6) years as a validation quality or engineering in regulated medical industries with significant knowledge of GxP practices. If with fewer years of experience it should be compensated by the level of education
OTHERS
- B2 English Proficiency
- Visa and Passport
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more