Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose Statement:
Support all API manufacturing activities to deliver to the business production plan, while meeting quality and safety compliance. Identify and drive production productivity improvement through yield improvement, waste and cycle-time reduction.
Responsibilities:
Operational and Technical
- Responsible for overseeing execution of batch manufacturing instructions in accordance with pre-defined procedures and training.
- Performs real-time monitoring of process critical steps and ensures flawless execution
- Provides inputs on operational and process related improvements to achieve site business targets and manufacturing excellence.
- Review and provides input in authoring of batch related recipes (POMS and DeltaV), manual operations and adhoc manufacturing documentations
- Provides input or review in design of batch/cleaning manufacturing recipe in DCS
- Lead digitalization projects that will support strategic business objectives
- Identify areas for process and operational streamlining. Be involved in continuous improvement (CI) projects.
- Oversee in all troubleshooting activities in processing issues, deviations and coordinating with other functions when require immediate and preventive actions.
- Provide training to chemical operators on Operation Standard Work (OSW), operational and equipment related changes, risk assessments.
- Assists in commissioning, qualification and validation activities during execution of all CAPEX related projects
- Lead and coordinate product and cleaning changeover activities
Safety
- Adheres to safe work environment in accordance with regulatory and global/local EHS policies
- Leads/participates in safety risks assessments or participates in process hazard analysis as an operations representative (PHA)
Quality
- Actively resolve batch related document errors in a timely manner
- Communicates all events/issues effectively with relevant stakeholders
- Provide inputs for investigation impact assessment and appropriate CAPA
- Ensures overall plant upkeep during the shift and ensuring plant is always in audit ready mode
Schedule
- Oversees deliverables ahead, anticipates complexities and prevents potential
- Ensures processes are running as per planned schedule with minimal delays. Highlights effectively to shift supervisor if delays are expected.
Qualifications
- Bachelor Degree in Engineering or equivalent. Master Degree desired but not required.
- Minimum of 4 years of pharmaceutical or industrial manufacturing experience.
- Ability to quickly know products and processes in order to assess performance issues.
- Demonstrates the highest levels of integrity and a strong work ethic.
- Able to work comfortably in 12-hour rotating shift (Day/Night)
- Good knowledge of GxP requirements and regulations.
- Good level of decision making and problem solving.
- Good planning and scheduling skills.
- Good communication skills both verbal and written.
- Good interpersonal skills.
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 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
