SOKOL GxP Services

Assistant Process Engineer – Cell Therapy Raw Materials

SOKOL GxP Services

contract

Posted on:

Location Type: Hybrid

Location: Seattle • New Jersey, Washington • 🇺🇸 United States

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Salary

💰 $29 - $35 per hour

Job Level

Mid-LevelSenior

About the role

  • 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

  • B.S. or M.S. 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.
  • 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.
  • Experience in Single Use Systems, GMP experience, Data Management.
Benefits
  • Competitive hourly rate: **$28.78 – $35.11/hr (W-2 only, no C2C)**
  • Working Hours: Monday - Friday, regular business hours
  • 6-month contract with possible extension
  • Health insurance, holiday pay, 401(k) program, and other benefits
  • Employee referral bonus program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Biochemical EngineeringChemical EngineeringBiomedical EngineeringCell BiologyImmunologyData ManagementQuality Management SystemGMP ManufacturingTechnical AnalysisRisk Assessment
Soft skills
Problem-solvingIssue ResolutionRoot Cause InvestigationDetail OrientedVerbal CommunicationWritten CommunicationInterpersonal SkillsLeadership SkillsCross-functional CollaborationTime Management