Aseptic Process Simulation Program Coordinator
AbbVie
September 04, 2026
On-site
Waco, TX
$96,500 - $183,500 USD yearly
Operations
Responsibilities:
- Lead the site-wide Aseptic Process Simulation (APS/Media Fill) program for sterile ophthalmic manufacturing in Waco, TX, ensuring compliance with GMP, FDA, EU Annex 1, and AbbVie quality standards.
- Develop, maintain, and execute the annual media fill strategy (routine, validation, and intervention-based process simulations).
- Serve as subject matter expert for APS design, execution, investigations, and regulatory inspection readiness.
- Collaborate with Manufacturing, Quality Assurance, Microbiology, Engineering, and Validation to ensure media fills reflect routine and worst-case conditions.
- Author/review/approve APS protocols, risk assessments, reports, and related quality system documentation.
- Lead investigations, root cause analyses, and CAPA for media fill failures or atypical events.
- Analyze APS performance metrics and trends; drive continuous improvement for contamination control and aseptic operations.
- Ensure personnel qualification/requalification aligns with media fill requirements and aseptic practices.
- Support regulatory inspections and customer audits with APS program results and compliance initiatives.
Preferred leadership focus:
- Provide technical leadership/mentorship, champion quality/compliance/operational excellence, and monitor industry/regulatory best practices.
Qualifications:
- Bachelor’s degree in science/technical field; MBA beneficial.
- 5–10 years’ experience across supply chain, customer service, manufacturing, engineering, or project management; strong strategy and project planning.
- Strong issue identification/problem solving; proficiency with program management communication tools.
- Knowledge of pharmaceutical manufacturing/supply activities; business financial systems knowledge.
- Collaborative mindset in a global environment; proven leadership and excellent communication.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); short-term incentive eligibility.
- Lead the site-wide Aseptic Process Simulation (APS/Media Fill) program for sterile ophthalmic manufacturing in Waco, TX, ensuring compliance with GMP, FDA, EU Annex 1, and AbbVie quality standards.
- Develop, maintain, and execute the annual media fill strategy (routine, validation, and intervention-based process simulations).
- Serve as subject matter expert for APS design, execution, investigations, and regulatory inspection readiness.
- Collaborate with Manufacturing, Quality Assurance, Microbiology, Engineering, and Validation to ensure media fills reflect routine and worst-case conditions.
- Author/review/approve APS protocols, risk assessments, reports, and related quality system documentation.
- Lead investigations, root cause analyses, and CAPA for media fill failures or atypical events.
- Analyze APS performance metrics and trends; drive continuous improvement for contamination control and aseptic operations.
- Ensure personnel qualification/requalification aligns with media fill requirements and aseptic practices.
- Support regulatory inspections and customer audits with APS program results and compliance initiatives.
Preferred leadership focus:
- Provide technical leadership/mentorship, champion quality/compliance/operational excellence, and monitor industry/regulatory best practices.
Qualifications:
- Bachelor’s degree in science/technical field; MBA beneficial.
- 5–10 years’ experience across supply chain, customer service, manufacturing, engineering, or project management; strong strategy and project planning.
- Strong issue identification/problem solving; proficiency with program management communication tools.
- Knowledge of pharmaceutical manufacturing/supply activities; business financial systems knowledge.
- Collaborative mindset in a global environment; proven leadership and excellent communication.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); short-term incentive eligibility.