About this role
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 Allergan’s 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 company’s operational success.Negotiate with customer areas and external representatives on priorities and tasks related to validation and associated studies, safeguarding the company’s key interests, and participate in the evaluation of changes to validated processes.Coordinate with various areas the plant’s 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 Abbvie‘s corporate procedure requirements.All other functions inherent to the position and those assigned by the immediate supervisor. EDUCATION
Bachelor’s, or Associate’s 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 ProficiencyVisa and Passport 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
