Senior Process Validation Engineer

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination products.

At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe.

We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.

We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.

Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries.

The Senior Process Validation Engineer owns validation strategy and execution for late-stage and commercial manufacture of a lipid MLV drug product. The role leads process characterization, engineering and readiness runs, PPQ, and transition to CPV using science- and risk-based approaches.
The successful candidate will integrate formulation and process science, statistical evidence, manufacturing controls, equipment capability, and quality-system requirements into protocols and reports that demonstrate a state of control. The role works closely within MSAT across programs and cross-functionally with Quality, Regulatory CMC, Analytical Development, Supply Chain, and CDMO partners.

• Validation lifecycle leadership:
  Develop and maintain the product/process validation strategy, validation master-plan inputs, traceability matrices, stage-gate deliverables, and lifecycle governance.
• Process characterization and control strategy:
  Translate development and scale-up knowledge into documented CQAs, CMAs, CPPs, proven acceptable ranges, in-process controls, normal operating ranges, and justified acceptance criteria.
• Lipid MLV process expertise:
  Define and validate controls for manufacturing unit operations or other final processing when applicable.
• Commercial PPQ:
  Author and execute statistically justified PPQ protocols and sampling plans; establish run prerequisites, bracketing or matrixing rationales where appropriate, enhanced monitoring, acceptance criteria, deviation pathways, and final reports. Lead cross-functional readiness reviews and ensure data are complete before batch disposition recommendations.
• Sterile and aseptic processing:
  For sterile operations, support contamination-control strategy implementation, sterilization and depyrogenation validation, sterilizing-filter validation and integrity testing, aseptic process simulations, environmental and personnel monitoring interfaces, bulk and sterile hold-time studies, and container-closure integrity.
• Equipment, utilities, cleaning, and systems:
  Ensure process requirements are traced to DQ/IQ/OQ and equipment capability. Provide process input to external partner readiness as they affect PPQ.
• Statistics and data integrity:
  Familiarity with DOE and tools such as JMP. Verify data (ALCOA+).
• Deviation and risk management:
  Lead or technically support FMEA and other quality-risk assessments, PPQ investigations, deviations, OOT/OOS assessments, RCA, CAPA, and impact assessments.
• Technology transfer and CDMO oversight:
  Confirm facility and equipment fit, assess scale-dependent risks, review batch records and site procedures, and provide on-floor technical oversight during engineering and PPQ campaigns.
• Regulatory and inspection support:
  Prepare or review…