Assistant Process Engineer - Raw Materials (Hybrid - Seattle, WA OR Summit/Warren, NJ)

Assistant Process Engineer – Raw Materials (Hybrid – Seattle, WA OR Summit/Warren, NJ) We are seeking an Assistant Process Engineer - Pharma for a global pharmaceutical client. You will join the raw materials team within the CTTO (Cell Therapy Technical Operations) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production. This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role at the client’s office, either in Seattle, WA OR Summit/Warren, NJ. This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.  Responsibilities:  Support as a SME for raw materials including single-use systems (SUS) and material sciences. Provide technical support on in CAR-T commercial manufacturing. Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications. Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials. Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes. Vendor management including change controls, audits, deviations, and QRM programs. Support investigations and ensure compliance with internal standards and requirements. Perform technical diligence visits to raw material supplier sites with cross-functional teams. Provide necessary technical analysis to support impact assessments and investigations. Support responses for Information Request (IR) from regulatory bodies.  Requirements:  0-3 years of experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent. Exposure to raw materials (both liquid and single use system). Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing. Experience working with vendors and contract manufacturing sites. Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Data management skills and comprehension skills of technical documents, such as process description documents. Experience in Single Use Systems, GMP experience, Data Management Ability to assess risk and develop contingency plans for process risks. Experience with Quality Management System (Ex. Deviation, CAPA, Change Management). Lean Manufacturing experience is desired. Knowledge of GMP manufacturing practices and documentation requirements B.S.  or M.S.    Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Assistant Process Engineer – Raw Materials (Hybrid – Seattle, WA OR Summit/Warren, NJ) role). Please feel free to forward this project opening to others who may be interested. Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.  Compensation: $32/hr. - $35.11/hr. #LI-SW1

Salary : $32 - $35