Senior Manufacturing Engineer

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