Aseptic Process Simulation Lead (Media Fill)

ABBVIE; Waco (TX); On-site; USD 97,000 - 184,000; Full time

Job summary

AbbVie in Waco, TX seeks an experienced Aseptic Process Simulation (Media Fill) Program Lead to head the site-wide program for sterile eye care manufacturing. You will align with GMP, FDA, and EU Annex 1 standards, coordinate cross-functional teams, and drive continuous improvement in aseptic processing.

The role requires 5–10 years in manufacturing/engineering/project management, strong leadership, and excellent communication skills. MBA preferred; bachelor’s in science/technical field required.

Qualifications

• Bachelor’s degree in science or technical field; MBA beneficial/preferred.
• 5–10 years experience across supply chain, customer service, manufacturing, engineering, and project management.
• Strong strategy development and planning skills with pharma manufacturing knowledge.
• Excellent problem identification and analysis to drive solutions.
• Proficiency with program management communication software tools.
• Knowledge of business financial systems and tools.
• Collaborative, globally oriented with strong leadership and communication.

Responsibilities

• Lead the APS/Media Fill program across the site to ensure GMP/FDA/EU compliance.
• Develop and execute the annual media fill strategy with validation and routine simulations.
• Serve as SME for aseptic process simulation design, execution, and investigations.
• Collaborate with Manufacturing, QA, Microbiology, Engineering, and Validation teams.
• Author, review, and approve APS protocols and related quality docs.
• Lead investigations, root cause analyses, and CAPAs for media fill events.
• Analyze performance metrics for continuous improvement and contamination control.
• Ensure personnel qualification integration with media fill requirements.

Skills

Strategy development

Pharma manufacturing knowledge

Problem analysis

Program management tools

Team collaboration

Leadership & communication

Influence others

Education

Bachelor’s degree in science or technical field

MBA degree beneficial/preferred

Job description

AbbVie in Waco, TX seeks an experienced Aseptic Process Simulation (Media Fill) Program Lead to head the site-wide program for sterile eye care manufacturing. You will align with GMP, FDA, and EU Annex 1 standards, coordinate cross-functional teams, and drive continuous improvement in aseptic processing.

The role requires 5–10 years in manufacturing/engineering/project management, strong leadership, and excellent communication skills. MBA preferred; bachelor’s in science/technical field required.