Staftonic LLC ยท 1 day ago
Senior Process Engineer
North Dakota, United States
Contract
Hybrid
Senior Level
5+ years expStaftonic LLC is seeking a Senior Process Engineer to lead process validation activities across the lifecycle in the biopharmaceutical industry. The role involves collaborating with various teams to ensure compliance with regulatory guidelines and performing advanced statistical analyses to support process improvements.
Information Technology & Services
Hiring Manager
Shaik Aleem
Responsibilities
Lead and execute process validation activities across the lifecycle, including process design, PPQ, and continued process verification (CPV)
Develop and author process validation protocols, PPQ protocols, reports, and validation summaries from scratch
Support validation efforts for drug substance operations (upstream cell culture, fermentation, and downstream purification) and drug product operations (formulation, aseptic filling, and finishing)
Collaborate with process development, manufacturing, quality, and MSAT teams to define critical process parameters (CPPs) and critical quality attributes (CQAs)
Perform advanced statistical analysis using JMP or Minitab to evaluate process capability, trends, and variability
Conduct trend analysis, control charting, and multivariate analysis to support data-driven decisions
Interpret large and complex datasets to assess process robustness and identify improvement opportunities
Ensure validation activities align with FDA, EMA, and ICH guidelines, including ICH Q8, Q9, and Q10
Support regulatory inspections and audits by preparing documentation, responding to inquiries, and presenting validation strategies
Participate in risk assessments (FMEA, risk ranking) and ensure appropriate mitigation strategies are implemented
Work closely with the Manufacturing, Quality Assurance, Quality Control, Process Development, and Engineering teams
Provide technical guidance during technology transfers, process changes, and deviation investigations
Support change control activities related to validated processes
Qualification
Required
5+ years of hands-on experience in process validation or process development within the biopharmaceutical or biotechnology industry
Strong experience supporting both Drug Substance (upstream/downstream) and Drug Product (aseptic fill-finish) operations
Demonstrated ability to independently design, execute, and document Process Performance Qualification (PPQ) activities
Proficiency with JMP or Minitab for statistical modeling, trend analysis, and process capability assessments
In-depth understanding of FDA and EMA regulations and quality risk management principles (ICH Q9/Q10)
Excellent documentation and report-writing skills with the ability to clearly communicate complex technical information
Company
Staftonic LLC
At Staftonic, we believe in turning possibilities into realities.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase