Process Engineer – Aseptic Filling
Meet Life Sciences, Columbus, OH, United States
Job Title:
Senior Validation Specialist, Aseptic Process Simulation (Media Fill)
Location:
Columbus, OH (Relocation Bonus)
Position Summary
Seeking an
APS (Aseptic Process Simulation) subject matter expert
to lead media fill strategy and execution for
sterile fill-finish operations
(small-volume vial filling). This is a highly specialized, hands‑on role focused specifically on
designing, writing, and executing APS protocols —not general validation.
Key Responsibilities
Own and execute
aseptic process simulation (media fill) program
Design
robust APS protocols , including worst‑case interventions (e.g., machine stops, aseptic manipulations)
Lead
end‑to‑end media fills
(protocol writing, execution, analysis, reporting)
Drive
deviation investigations, root cause analysis, and revalidation
Support
process validation (PPQ/CPV)
and contamination control strategies
Ensure compliance with
FDA and EU GMP Annex 1
requirements
Partner cross‑functionally with Manufacturing, QA, MS&T, and Microbiology
Support
audits and regulatory inspections
Required Experience
5+ years in
sterile injectable manufacturing
(pharma/biopharma)
Direct experience
writing and executing APS/media fills
Strong knowledge of
aseptic processing, contamination control, and risk‑based validation
Experience with
small‑volume vial filling (1,000–2,000 units/batch)
preferred
Ideal Background
Hands‑on
aseptic filling operator experience
(strong plus)
Experience in
Validation, MS&T, Process Engineering, or Manufacturing
Biologics or gene therapy manufacturing experience preferred
Bachelor’s or Master’s degree preferred (Associate’s considered with strong hands‑on experience; PhD not typical for this role)
Additional Notes
Title flexibility (e.g., Validation vs. Process Engineering) to better match candidate backgrounds
Fast-moving process
with potential for immediate hire
High‑impact role supporting
sterile manufacturing of advanced therapies
#J-18808-Ljbffr
Senior Validation Specialist, Aseptic Process Simulation (Media Fill)
Location:
Columbus, OH (Relocation Bonus)
Position Summary
Seeking an
APS (Aseptic Process Simulation) subject matter expert
to lead media fill strategy and execution for
sterile fill-finish operations
(small-volume vial filling). This is a highly specialized, hands‑on role focused specifically on
designing, writing, and executing APS protocols —not general validation.
Key Responsibilities
Own and execute
aseptic process simulation (media fill) program
Design
robust APS protocols , including worst‑case interventions (e.g., machine stops, aseptic manipulations)
Lead
end‑to‑end media fills
(protocol writing, execution, analysis, reporting)
Drive
deviation investigations, root cause analysis, and revalidation
Support
process validation (PPQ/CPV)
and contamination control strategies
Ensure compliance with
FDA and EU GMP Annex 1
requirements
Partner cross‑functionally with Manufacturing, QA, MS&T, and Microbiology
Support
audits and regulatory inspections
Required Experience
5+ years in
sterile injectable manufacturing
(pharma/biopharma)
Direct experience
writing and executing APS/media fills
Strong knowledge of
aseptic processing, contamination control, and risk‑based validation
Experience with
small‑volume vial filling (1,000–2,000 units/batch)
preferred
Ideal Background
Hands‑on
aseptic filling operator experience
(strong plus)
Experience in
Validation, MS&T, Process Engineering, or Manufacturing
Biologics or gene therapy manufacturing experience preferred
Bachelor’s or Master’s degree preferred (Associate’s considered with strong hands‑on experience; PhD not typical for this role)
Additional Notes
Title flexibility (e.g., Validation vs. Process Engineering) to better match candidate backgrounds
Fast-moving process
with potential for immediate hire
High‑impact role supporting
sterile manufacturing of advanced therapies
#J-18808-Ljbffr