Assistant Process Engineer

Assistant Process Engineer

Location:

Seattle, WA / Summit, NJ

Compensation: $28.78 - $35.11 per hour
Type:
Contract

• B.S. or M.S. with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline.
• 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.
• Ability to assess risk and develop contingency plans for process risks.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.
• Experience with Quality Management System (Ex. Deviation, CAPA, Change Management).
• Knowledge of GMP manufacturing practices and documentation requirements.

• 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.

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.