Assistant Process Engineer
Job Number: 25-05742
Job Number: 25-05742
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an Assistant Process Engineer for our client in Seattle, WA.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- Looking for an 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:
- 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.
Required Qualifications:
- B.S. with 0+ years of experience or M.S. with 0+ years relevant 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.
- 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.
- 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.
Pay Rate: $35 - $37 / Hour
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
212-804-7476
June Binuya | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
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