Job DescriptionWe believe the paths we take to achieving our breakthroughs matter.
At AbbVie, everyone of our 50,000* employees is a part of shaping those paths—and defining our way forward.We are now recruiting experienced Manufacturing Analyst to join our Core 1 Operations team in AbbVie Westport, Co Mayo. In the role, you will be performing focused work to provide technical support to the business specifically on the 607 project.
You will also support day-day operations activities within the operations function. Other aspects of this role are QMS, compiling and review of project documentation (e.g., SOPs, methods, Master records, Batch Records, Reports).
The candidate will also be coordinating with several departments to holistically develop technical and leadership skills.If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:Key activities:Provide technical support to all manufacturing and chemistry related issues.
Tasks include, daily trouble shooting, optimization, cost reduction, training and coaching of manufacturing personnelSupport of process front runs / use tests for both NPI and commercial processes.When required support commercial operation activitiesDevelopment of process control recipes for NPIs and optimization of existing commercial process recipesEnsure all batch records components are present and that all corrections identified during initial review and by Product Release Team are addressed in a timely and compliant manner.Use and maintenance of data within key systems such as SAP, S4HANA.Participate in non-conformance and exception investigations as necessary.Work with QA Teams to align and promote awareness on data integrity and good documentation practices.Facilitate and coordinate with project teams to enhance, improve and streamline batch records.Provide on-the-floor technical support to the Production Team Leaders for process/equipment optimization and troubleshootingProvide assistance when required at Regulatory Inspections.Trending and c-ordination of customer complaints investigations.Work close with department on corrective actions arising from Environmental excursions.
Comply with AbbVie policies and procedures and regulatory agency regulations.QualificationsEducation and preferred experience:Bachelor's degree in science, or a related field is preferred and/or a minimum of 2 years' experience in a similar role.Detailed knowledge of CGMP and aseptic practices, data integrity requirements and GDP is required for this role.Strong organizational skills and attention to detail are essential for this role.Good interpersonal relations/communications skillsAdditional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn