Process Validation Engineer
Core
Execute process validation activities for oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing, covering FDA lifecycle stages 1, 2, and 3.
Role type
Process Validation Engineer (GMP API)
Builds
Oligonucleotide APIs
Domain
Biopharmaceuticals / Oligonucleotide Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP API manufacturing experience, unit operations control strategy, risk assessment, Design of Experiments (DOE), statistical analysis, CGMP protocol execution, batch record review, continued process verification (CPV)
Preferred skills
SAS JMP software proficiency, laboratory scale experiment execution
Technologies
SAS JMP
Responsibilities
Develop and refine manufacturing control strategies for oligonucleotide unit operations; Identify, assess, and mitigate process risks; Execute Design of Experiments (DOE) and Proven Acceptable Range (PAR) studies; Lead and support Process Performance Qualification (PPQ) studies in a CGMP setting; Evaluate change controls and nonconformances; Support Continued Process Verification (CPV) plans and reporting; Review commercial batch records for alignment with control strategies.
Seniority
Senior, hands-on IC
