Software-engineer Careers in warren ∙ Page 2

Description

We are looking for a Associate Engineer to 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.

Responsibilities include, but are not limited to, the following:

• 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.

Prerequisites:

• Experience in Single Use Systems, GMP experience, Data Management.

Additional Skills:

• Understanding of key considerations for single-use containers used for raw materials.
• Familiarity with raw material supply chains and manufacturing methods.
• Data management and grasp apprehension of technical instructions.
• Lean Manufacturing experience is desired.

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