Title : Engineering - Scientist
Location : New Brunswick NJ
Duration : 06+ Months
Pay rate : $60.73 / hr
Job Description : 50% onsite required
Work Schedule : Normal business hours
Position Summary :
The Scientist provides technical support related to one or more Technology Transfer (TT) projects as well as provide support to the Product Champion cluster.
- This position is accountable for working together with the TT Lead to ensure various project aspects are supported from a technical perspective as well as a timeline perspective.
- This position is responsible for supporting the Product Champion group through Data Verification (DV) activities, change control support, improvement projects, etc.
Duties / Responsibilities :
Support TT Lead for one or more projects
- Actively participates in TT meetings, collaborating with cross-functional group.
- Responsible for detailed reviews of project documents such as protocols, reports, risk assessments, and MBRs.
- Provides assistance to sites to review / resolve quality events as needed.
- Collaborate on TT project definition and support chartered projects as needed.
- Identifies TT issues / risks and proposes ideas for issue resolution. Supports issue resolution as needed.
Support Product Champion Cluster
- Support DV of various product TTs and lifecycle projects.
- Support improvement projects for Product Champion group.
- Identify opportunities for improvement and provide ideas to implement.
- Collaborate with Product Champions and work together to learn about different products and implement various improvements.
Reporting Relationship Reports to Product Champion Cluster Lead
Specific Knowledge, Skills, Abilities :
Required :
Knowledge in Biologics / sterile liquid drug products, aseptic processing
Experience in Biologics / Vaccine Aseptic Drug Product Manufacturing and / or Technology Transfer
Ability to serve as a technical expert for Drug Product manufacturing
Strong critical thinking, technical writing, and verbal communication
Demonstrated ability to :
Work in a matrix environment and effectively support the decentralized manufacturing function.
Effectively collaborate with other functions.
Desired :
Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
Education / Experience / Licenses / Certifications :
Required Bachelor’s degree in engineering / science-related field with 3-5 years of relevant experience. Time spent in advanced degree program may consider as equivalent experience.
Travel :
This position does not require travel.
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