Job Summary:
As the Principal Engineer, Process Validation and member of the MSAT (Manufacturing Science & Technology) organization, you are responsible for the successful process validation activities for Artiva's allogeneic manufacturing processes. In this role, you will be responsible for manufacturing process validation in our biopharmaceutical plant, including assessment of process characterization, validation activities at scale and continued process verification.
Duties/Responsibilities:
- Responsible for authoring, execution, and documentation of process validation protocols and reports in alignment with regulatory expectations (FDA, EMA, ICH) as well as of studies intended to demonstrate the suitability and robustness of manufacturing processes.
- Support the full process validation lifecycle - Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).
- Develop and maintain control strategy elements, process monitoring plans, and CPV trending.
- Responsible for the management of technical risks associated with process validation, and project completion aligned with project management goals.
- Works closely with MSAT process experts as well as cross functionally with QA, QC, PD, Manufacturing and Regulatory Affairs to ensure communication of critical process and of technical information to meet the required deadlines.
- Ensures timely compilation of assessments of change requests and process validation related deviations.
- Responsible to author CMC sections in filing documents and technical content of validation reports. Participates in continuous improvement initiatives and in the development of validation lifecycle strategies.
- Generously shares information and knowledge with other across teams and functions. Demonstrates high integrity.
- Support the full process validation lifecycle - Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).
- Develop and maintain control strategy elements, process monitoring plans, and CPV trending.
Requirements:
- Bachelor's, Master's or PhD degree in biotechnology, chemical engineering or related disciplines.
- Proven experience in managing complex projects.
- Minimum 2 years of experience in process validation within a cGMP-regulated biopharmaceutical environment. Experience in process development, process scale up and / or manufacturing is a plus.
- Strong technology transfer experience necessary.
- Working experience in biopharma manufacturing and / or MSAT.
- Excellent technical writing skills with deep understanding of ICH, FDA and EMA guidelines and GMP environment.
- Excellent communication and stakeholder management skills.
In addition to a great culture, we offer:
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
Base Salary: $ 170,000 - $185,000. Exact compensation may vary based on level, skills and experience.
