What are the responsibilities and job description for the Senior Process Engineer position at Cynet Systems?
Job Details
We are looking for Senior Process Engineer for our client in Morristown, NJ
Job Title: Senior Process Engineer
Job Type: Contract
Job Description:
Job Description:
Pay Range: $55.67hr - $60.67hr
Responsibilities:
- Makes technical and business-based recommendations on pharma and packaging processing supporting product development for both new and marketed pharmaceutical product projects.
- Develops test protocols and manages execution of various studies including transport qualification for bulk and finished drug product and packaging finished goods.
- Acts as technical and coordination focal point for sites and external CMOs for multi- site projects regarding technical documentation.
- Define activities and developed project plans that meet the defined objectives.
- In certain situations, acts as Project Manager to plan and manage all technical activities for successful introduction of products from development stages to the commercial market.
- Identifies new processes for pharma and packaging technologies and/or applications that could improve cost, compliance, and quality and/or customer acceptance.
- Represents Manufacturing & Supply in the development, qualification, dossier preparation and launch of new products.
- Project teams, Tech Transfer Teams, Launch Teams, and Packaging Task Force sub teams.
- Supports the GDPU and MSAT in evaluations of primary packaging material systems as considerations to individual project objectives.
- Makes recommendations for equipment for pharma and packaging processes, new drug product stability programs based on product protection, technical performance, and cost considerations.
- Identifies new technologies, processes and/or applications that could improve cost, compliance, and quality and/or customer acceptance which improves industry positioning for.
- Solid project management skills with varied scope and complexity with multi- functional/organizational project teams.
- Demonstrates comprehensive knowledge of solid and liquid oral processes and packaging material types and their technical performance characteristics, cost, and manufacturing processes.
- Working knowledge to advanced understanding of principles and applications behind the packaging materials testing and performance requirements defined in USP, ASTM, ISTA, IATA, CFR, and FDA Guidance.
- Has comprehensive knowledge of the related pharmaceutical customer, supply and distribution requirements and considers their wants/needs into pharma processes and packaging solutions.
- Has knowledge of FDA and EMA Regulations regarding required documentation and data to support new product registrations.
- Strong project management experience; strong technical writing skills; proficiency with MS Office tools (e.g., responsibilities include authorship of Technical Packaging Reports).
- Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
- Experience in equipment start-up, qualification, and validation (Process and Packaging).
- Bachelor's Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering.
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Salary : $56 - $61
