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 NJ 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 NJ 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

Benefits of Working at Quva:

Set, full-time, consistent work schedule
Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
12 PTO, 5 PLP paid days off plus 8 paid holidays per year
Occasional weekend and overtime opportunities with advance notice
National, industry-leading high growth company with future career advancement opportunities
The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions
Range: $98,891 - $135,975 Annually

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.

It is the policy of Quva to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender,

transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

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Process Improvement Engineer II