Process Improvement Engineer II

About the role

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, and project management. Responsibilities include implementing deviation reduction projects, supporting complex product-specific deviation investigations, writing and executing process validations and reports, and authoring complex Technical Assessments and other technical documents. This role 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.

Responsibilities

• Lead cross-functional teams to implement complex project improvement initiatives related to formulation and compounding, including semi-automated systems.
• Develop and implement the NJ site air visualization program, coordinating with Sterility, Operations, and Quality to ensure the program meets FDA expectations and aligns with the NJ facility’s program.
• 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 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, including root cause investigations and CAPA development.
• Engage with Commercial Operations to ensure production processes are designed to meet on-time supply of products to customers.
• Provide Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to production performance.
• Investigate and execute risk-based solutions to address business operational and compliance challenges related to production processes.
• Conduct process characterization experiments, analyze data, and prepare technical summaries to 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 automated controls and/or engineering to ensure process consistency and operational readiness.
• Support 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.

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.
• Ability to motivate 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 project management experience.
• 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, and equipment.
• Ability to perform physical activities such as 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 the 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

• Set, full-time, consistent work schedule.
• Comprehensive health and wellness benefits including medical, dental, and vision.
• 401k retirement program with company match.
• 12 PTO days, 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.

Pay

The base compensation for this role is estimated to be within the range of $98,891 - $135,975 annually. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions.