Job Title: Manufacturing Process Specialist
Key Responsibilities:
* Own and maintain manufacturing equipment, process knowledge, and technology.
* Source and procure process equipment, including technical oversight of procurement processes.
* Provide technical support for the manufacturing process and equipment.
Collaborate closely with cross-functional teams to ensure consistency in technical approach and standards, driving best-in-class performance.
Design and implement technical studies and programs as necessary to support investigations and product improvements.
Develop knowledge of new pharmaceutical manufacturing processes aligned with company business objectives.
Identify and project manage continuous improvement initiatives.
Monitor and analyze process data during drug product manufacturing.
Support technology transfer projects by planning, executing, and reporting on process-related aspects.
Lead teams in identifying root cause and corrective actions for process deviations using problem-solving methodologies.
Assume accountability for risk assessments, including hazards, for employee and visitor health and safety.
Develop and modify procedures as needed to support manufacturing operations.
Participate in process, equipment, and facilities validations efforts and project implementations.
Consult with operations, quality, and S&T to maximize equipment and process performance.
Required Skills and Qualifications:
* Relevant third-level qualification in science, engineering, or technical discipline.
* Masters or PhD in engineering, chemical, or process engineering advantageous.
* Minimum 3 years' experience in pharmaceutical process engineering, including batch processing, technical transfers, scale-up, commissioning, and validation in a cGMP pharmaceutical or Biologics industry.
* Demonstrated project management skills, including delivering projects on schedule, within budget, and meeting predefined quality requirements.
Previous experience in lyophilization and sterilization operations preferred.
Benefits:
AbbVie is an equal opportunity employer, committed to integrity, innovation, transforming lives, and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation may click here to learn more.