Job Number: 21-02111
Job Number: 21-02111
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Process Engineer for our client in New Brunswick, 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!
Conducts product and process characterization studies; collaborates with research and development in drug product process development of sterile parenteral and biologics drug product and works with manufacturing sites to characterize, troubleshoot or optimize processes for lifecycle products. This position is accountable for the design and execution of process characterization to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, and providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements.
- Execution of post-market process change activities/experiments through partnership with R&D development assets
- Responsible for characterizing, optimizing and troubleshooting product and manufacturing processes of parenteral dosage forms
- Work with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations
- Effectively represent biologics drug product manufacturing science and technology in various internal and external teams and committees on development, technology transfer, manufacturing, specifications, process validations and launch
- Provide assistance to sites globally to resolve significant quality events and manage complex change controls
- Bachelor’s degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering)
- Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment
- Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial drug product manufacturing, and their unit operations
- In-depth understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQA's
- Able to design and execute scientifically sound, hypothesis driven experiments
- Skilled in writing and reviewing complex study plans and scientific reports
- Possess high level of familiarity with sterile product processing equipment and manufacturing facilities
- Overall knowledge of parenteral technology: aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, etc.
- Strong understanding of project management systems and tools
- Master or advanced degree
- Six Sigma Green/Black Belt certification
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:
Maria Castañeda | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status