The Process Improvement Engineer II plays a critical role in the development of new processes, identification and implementation of process efficiency projects, leading complex cross functional teams/project management, implementation of deviation reduction projects, supporting complex product specific deviation investigations, writing and executing process validations and reports, writing complex Technical Assessments and other technical documents. The resource is also responsible for building and implementing the TX site airflow visualization studies (smoke study program) essential for cleanroom validation and contamination controls. Working closely with R&D, Manufacturing, Quality, Operations, and Regulatory teams, the resource contributes to experimental design, data analysis, process documentation, and readiness activities that enable Quva to meet increased demand and compliance commitments right first time.

Key Duties and Responsibilities:

• Lead cross functional teams to implement complex project improvement initiatives related to formulation and compounding including semi-automated systems
• Development and implement the TX site air visualization program including coordination of various functional responsibilities from sterility, operations, and quality to ensure the program meets FDA expectations and is aligned with the program implemented at the NJ facility
• of personnel dedicated to research, design, and execution of new product formulation introduction and commercialized product improvement objectives
• Execute formulation and compounding feasibility studies using science based and risk-based methodologies to support process efficiency projects

• Execute process validation and product transfer validations for new products and existing marketed products to support product lifecycle compliance

• Partner with Manufacturing, MS&T, and Operations teams to troubleshoot product specific or complex process deviations, equipment issues, and performance challenges to support deviation reduction projects required to maintain compliance including root cause investigations and corrective/preventive action (CAPA) development
• Engaging with Commercial Operations to ensure production processes are appropriately designed to ensure on-time supply of products to meet customer requirements
• Provide Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to production performance
• Investigating and executing risk-based solutions deemed necessary to address business operational and compliance challenges related to production processes
• Conduct process characterization experiments, analyze data, and prepare technical summaries ensure process adequacy for commercial implementation
• Assist in evaluating new technologies, equipment, and analytical tools that improve product robustness and manufacturability
• Provide hands on execution of scale-up activities/validations and implementation of process changes to improve process efficiency including implementation of any automated controls and/or engineering ensuring process consistency and operational readiness
• Provide hands-on support for product and/or process technology transfer from R&D to sites, between internal manufacturing sites, or from existing sites to external CMOs, ensuring alignment on process controls, equipment capability, and documentation requirements
• Support continuous improvement initiatives aimed at enhancing yield, reducing variability, and strengthening process reliability
• Participate in regulatory inspections and technical discussions as a subject matter contributor
• Provide hands-on management of process optimization projects, and cost-reduction initiatives
• Generate technical documentation such as Technical Assessments, Technical Position Papers, and Product Evaluations
• Provide hands on execution of product packaging configuration validations and shipping lane validations

Competencies / Skills:

• Strong understanding of GMP, ICH guidelines, QbD principles, and CMC expectations
• Hands-on experience with formulation, process development, scale-up, process validation or tech transfer
• Experience with Airflow Visualization studies and requirements
• Motivating cross functional teams to meet stretched timelines
• Ability to interpret complex data sets and make evidence-based recommendations
• Effective communication and cross-functional collaboration skills including experience with project management
• Demonstrated problem-solving ability in manufacturing or development environments
• Proficiency in technical writing, MS Office, and familiarity with electronic documentation systems

Work Environment:

• Ability to sit and/or stand 8 hours or more per day if needed
• Ability to manipulate necessary office equipment, computer software, hardware & equipment
• Ability to perform the following physical activities: stooping, reaching, standing, grasping, walking, feeling, talking, and hearing
• Occasionally lift up to 40 lbs.

Qualifications:

• BS, MS, or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or translatable work experience
• 7+ years of experience working in sterile drug manufacturing, technical operations, process validation, MS&T, or related functions
• Experience in Airflow Visualization studies and programs in pharmaceutical industry
• Experience supporting scale-up, process improvement/efficiency projects, tech transfer, and manufacturing investigations
• Exposure to regulatory submissions or CMC documentation is a plus
• Demonstrated ability to work in fast-paced environments undergoing growth or scale-up
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.