About Aerogen Pharma: 
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 

What is the role? 
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. 

What are the key responsibilities? 
• 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 validation content for IND, BLA, NDA, MAA, supplements, responses to health-authority questions, and pre-approval or routine inspections. Maintain traceable rationales aligned with the registered process and control strategy. 
• Continued process verification: Define the CPV plan, parameters, alert/action approaches, review cadence, escalation rules, and annual product-review inputs. Support ongoing verification of the validated state. 
• Technical leadership: Set document and data-quality expectations, facilitate cross-functional decisions, communicate risk to senior stakeholders, and manage priorities. 

What education and experience are required? 
• Bachelor's or Masters degree in chemical, biochemical, pharmaceutical, mechanical, or biomedical engineering; pharmaceutical sciences; or a closely related discipline. An advanced degree is preferred. 
• Typically 8+ years of pharmaceutical or biopharmaceutical process, manufacturing, MSAT, or validation experience, including at least 5 years in a GMP environment and substantial direct ownership of process validation deliverables. 
• Demonstrated leadership of at least one late-stage or commercial PPQ campaign from protocol strategy and readiness through execution, deviation closure, final reporting, and transfer into CPV. 
• Direct experience with lipid-based, liposomal, vesicular, emulsion, or other complex colloidal drug products. Hands-on knowledge of multilamellar vesicle formation, scale-up sensitivities, and product-specific analytical characterization is strongly preferred. 
• Experience with sterile product manufacturing, aseptic fill-finish, lyophilization, controlled mixing, and sterilizing filtration is strongly preferred and may be required based on the final dosage form. 
• Proven authorship and defense of validation protocols, reports, risk assessments, sampling plans, deviations, CAPAs, change controls, and CMC-supporting technical documents. 
• Experience working with CDMOs and matrixed Quality, Manufacturing, Regulatory, Analytical, and Supply organizations; prior inspection or pre-approval inspection support is desirable. 

What key skills will make you great at the role? 
• Process-validation mastery: Expert working knowledge of lifecycle validation, PPQ design and execution, CPV, validation-maintenance assessments, and the interfaces among process validation, equipment qualification, cleaning validation, analytical readiness, and computerized systems. 
• MLV product and process understanding: Ability to connect process unit operations from compounding through fill finish to manufacturing controls. 
• Scale-up and engineering fundamentals: Strong command of mixing and mass-transfer principles, understanding of CQA impacts due to process unit operations, equipment geometry, and other scale-dependent sources of variability 
• Quality risk management: Skilled in FMEA, hazard analysis, risk ranking, control-strategy development, and evidence-based decisions consistent with patient risk and product knowledge. 
• Applied statistics: Proficient in DOE, sampling-plan development, measurement-system considerations, SPC, process capability, equivalence or comparability analysis, and scientifically appropriate handling of small PPQ data sets. 
• GMP execution: Strong documentation discipline, data integrity, deviation and CAPA management, change control, protocol adherence, inspection readiness, and ability to make sound decisions during live manufacturing operations. 
• Technical writing and communication: Ability to write clear, auditable protocols and reports; distinguish requirements from recommendations; summarize complex data; and defend conclusions to Quality, leadership, and regulators. 
• Program leadership: Strong planning, facilitation, influence, mentoring, and issue-escalation skills, with the ability to deliver across multiple functions, sites, time zones, and external manufacturing organizations. 

Regulatory, Compendial, and Industry Knowledge 
• Core regulations and guidance: Current working knowledge of 21 CFR Parts 210 and 211, 21 CFR Part 11, FDA Process Validation: General Principles and Practices, EU GMP Annex 15, EU GMP Annex 1. 
• ICH quality framework: Practical application of ICH Q8(R2), Q9(R1), Q10, Q11, and Q12 to process understanding, risk management, pharmaceutical quality systems, lifecycle management, and post-approval change strategy. 
• Lipid/liposome-specific expectations: Familiarity with FDA's Liposome Drug Products guidance and the need to link process robustness to product performance. 
• Industry standards: Familiarity with ASTM E2500, ISPE commissioning and qualification principles, PDA technical reports, and site procedures relevant to sterile processing, filters, cleaning, hold times, statistics, and validation. 

Preferred Certifications and Training 
• ASQ Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA) is preferred. 
• Lean Six Sigma Green Belt or Black Belt is desirable for structured problem solving, variation reduction, and statistical improvement work. 
• Project Management Professional (PMP) or equivalent program-management training is desirable for launch-readiness programs. 
• Formal training or certificate coursework from ISPE, PDA, USP, or an equivalent recognized provider in process validation, aseptic processing, statistics/DOE, cleaning validation, or pharmaceutical quality systems is desirable. 
• Professional credentials complement but do not replace demonstrated ownership of successful GMP validation and commercial PPQ programs. 

Why Aerogen Pharma? 
As a key member of Aerogen Group, the global market leader in high-performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. 
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged. 

Equal Employment Opportunity 
Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law. 

Salary Range and Benefits 
Salary Range for this position is estimated at $138,000-$165,000 and will depend on the candidate's skills, qualification and experience. The role is eligible for a performance-based incentive bonus and comprehensive benefit package including Medical, Dental, and Vision Coverage, 401k Retirement, Enhanced Global Life Insurance, Paid Time Off (15-20 days tenure related), Global EAP Program, Short-Term Disability and FMLA Benefits. The company reserves the right to adjust this pay range at any time.