CEL - Scientist/Engineer
CEL - Scientist/Engineer
JobDiva # 21-05245
JobDiva # 21-05245
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a CEL - Scientist/Engineer for our client in Summit, NJ.
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!
- The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.
- The incumbent will be working 80% to 90% of the time in an office environment.
- The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
- The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
- The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.
- Working experience of deviation investigations utilizing root cause analysis tools.
- Working experience in the CAPA process and ability to identify and verify effectiveness.
- Technical writing skills and ability to collaborate effectively in cross functional teams.
- Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
- Ability to support health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software a plus.
- Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
- Ability to set priorities, manage timelines and effectively react/manage changing priorities.
- Ability to work with management (global and site) and support corporate and departmental goals.
- Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
- Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
- Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
- Ability to train new team members on the investigation process
- Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
- Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.
- Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
- An equivalent combination of education and experience may substitute.
- Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
- Lead investigations and cross functional investigation teams, and close reports in a timely manner
- Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.
- Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
- Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
- May Initiate change control documentation
- Identify functional area SMEs to perform impact assessments as part of the change management process.
- Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
- Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Provide training to new investigations team members
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR T products as needed.
- Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
- Continuously support S12, living the "patients first mission and fostering a "Right First Time mindset.
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:
John Bayog | LinkedIn
Equal Opportunity Employer:Eclaro values diversity anddoes not discriminate based onRace, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.