Senior Manufacturing Specialist

Purpose Statement

• Ensure operational efficiency and compliance by managing technical documentation addressing non-conformances and implementing corrective actions.
• Streamline processes and drive continuous improvement across manufacturing operations.
• Effective change management thereby fostering process enhancements and ensuring compliance with regulatory standards. 

Operations and Technical

• Conduct technical writing and collaborate with Operations and cross-functional team to investigate non-conformance issues.
• Develop and implement corrective and preventive measures together with the Operations team and cross-functional team.
• Manage change processes to enhance operations.
• Develop and conduct training modules for Operations and new employee onboarding.
• Analyze key performance indicators and execute strategies to optimize workflows.
• Author and revise GMP-related documents.
• Collaborate on the creation revision and enhancement of electronic batch records.
• Lead or participate in projects aimed at enhancing operations or new product introduction.
• Utilize quality management systems and operations-related software such as Trackwise LIMS SAP POMSnet Delta-V or others.
• Prepare and support regulatory inspections and internal audit.
• Engage in projects aimed at continuous operational improvement.
• Engage in regular GEMBA walkdowns.
• Organize regular meetings with cross-functional teams to discuss and update daily operational matters.

Safety

• Ensures a safe work environment by adhering to regulatory and global/local Environmental Health and Safety (EHS) policies.

Quality

• Ensure investigations are conducted and completed promptly and to a high standard.
• Ensure that process improvements are relevant and beneficial to the manufacturing operations.
• Verify the accuracy of impact assessments and ensure corrective and preventive actions are relevant.
• Serve as point of contact for change management documentation and investigations during audits and inspections.

Schedule

• Strive to complete investigations in a timely manner to minimize any potential impact on batch release timelines or shipment schedules.
• Ensure that process improvement changes are executed on schedule as planned for the production run.

Qualifications :

• Master or Degree with at least 5-7 years relevant experience in Biologics Production facility or
  equivalent.
• Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred.
• Strong working knowledge of GMP systems such as Trackwise SAP LIMS MES systems are preferred.
• Experience with cGMP documentation and record maintenance.
• Experience with Regulatory inspections is required.
• Strong ability to lead and drive cross-functional teams.
• Possesses a positive work attitude and a strong determination to complete tasks efficiently.
• Agility capable of performing under pressure and able to address various priorities.
• Good presentation and strong technical writing 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