Assistant Process Engineer in Seattle
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Job Description
JOB TITLE: Assistant Process Engineer
Location: Seattle, WA (50% onsite)
Duration: 6 months initial (potential extension/potential right to hire)
Job Purpose / Position Summary
The client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. We are developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.
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.
Skills/Knowledge Required:
• 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
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.
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 you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to June@eclaro.com or call (212)804-7476.
Equal Opportunity Employer: Eclaro values and does not discriminate based on , , , , , , , , Genetic Information, , Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
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