Junior Scientist/Engineer

2 weeks ago

Akron, Ohio, United States Synectics Inc Full time
Job Overview

Position Summary:

  • Execute comprehensive assessments (Environmental Monitoring, deviations, etc.) using root cause analysis methodologies.
  • Facilitate investigations and collaborate with cross-functional teams, ensuring timely closure of reports.
  • Conduct GEMBA walks with stakeholders to gain insights into process steps and evaluate Root Cause Analysis.
  • Collaborate with various teams to recommend effective Corrective and Preventive Actions (CAPAs), develop CAPA strategies, and verify their effectiveness.
  • Evaluate potential impacts and risks to products or processes that may arise from changes and formulate suitable mitigation strategies.
  • May initiate documentation for change control.
  • Identify subject matter experts within functional areas to conduct impact assessments as part of the change management process.
  • Ensure timely completion of all investigations and promptly inform stakeholders of any delays.
  • Provide technical assistance for manufacturing investigations, CAPAs, and change controls.
  • Support the defense of deviation investigations during audits and inquiries related to site inspections.
  • Address complex issues and resolve problems with minimal supervision.
  • Act as an author or technical reviewer for departmental procedures.
  • Apply lean manufacturing and six sigma principles to enhance products, processes, and systems continuously.
  • Consistently support S12, embodying the "patients first" mission and promoting a "Right First Time" mindset.
  • The Junior Scientist/Engineer is accountable for leading investigation reports in support of S12 CART operations.
  • This role involves conducting thorough root cause investigations, interviewing personnel, testing hypotheses, interpreting results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex issues.
  • The successful candidate must closely collaborate with various functional organizations, including Quality Assurance teams.
  • Work Schedule: Wed-Sat- (7am-5pm) EST.

Essential Qualifications:

  • A Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences, or a related engineering field (advanced degree preferred).
  • Experience in deviation investigations utilizing root cause analysis tools.
  • Familiarity with the CAPA process and the ability to identify and verify effectiveness.
  • Proficient technical writing skills and the ability to collaborate effectively within cross-functional teams.
  • Proven capability to understand, interpret, and apply Global Regulatory and cGMP requirements accurately.
  • Ability to assist during health authority inspections.
  • Knowledge of data trending and tracking, including the use of statistical analysis software is advantageous.
  • Demonstrated advanced problem-solving skills, technical proficiency, and logical reasoning.
  • Capacity to prioritize tasks, manage timelines, and adapt to changing priorities effectively.
  • Ability to work collaboratively with management (global and site) and support corporate and departmental objectives.
  • Strong communication skills to convey information transparently and effectively with peers and management.
  • Proficiency in utilizing electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system) or Infinity.
  • Hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control is preferred.
  • A minimum of 1 year of relevant work experience, ideally in a health authority regulated environment.
  • Previous experience in a biopharmaceutical manufacturing facility is preferred (CAR T experience is a plus).

Benefits:

Healthcare Insurance: Synectics provides eligible employees and their dependents with healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the first day of the calendar month following 60 days of continuous full-time employment with Synectics, with premiums subsidized by the company.

Dental Insurance: Eligible employees and their dependents can access a dental plan through MetLife, effective on the first day of the calendar month following 60 days of continuous full-time employment.

Vision Insurance: Vision insurance is available to eligible employees through VSP, starting on the first day of the calendar month following 60 days of continuous full-time employment.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan allows employees aged 21 and older to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins.

Technical Certification Bonus: Synectics awards a bonus of up to $500 for approved professional certifications related to the current position, achieved during employment. Only one Certification Bonus per calendar year may be awarded per employee, and it will be granted 90 days after documentation confirming successful completion is received.

Synectics is an equal opportunity employer.

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