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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
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 Techni...
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
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