USA-Process Engineer III Engineering
USA-Process Engineer III Engineering
Posted on :
09-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
09-04-2025
Job Description
Responsibilities:
- Support activities within MSATUS regarding technical documentation SOPs and internal systems.
- Development of technical positions regarding packaging and Pharma process equipment material and component performance and Regulatory compliance for Client packaging process practices. This includes investigating and recommending new packaging and Pharma processes technologies systems and materials for potential integration into Client packaging and Pharma manufacturing systems.
- Provide both technical and project management support as needed for CMC and packaging projects in the perimeter of MSAT in support of late stage NCE development Life Cycle Management Programs (LCM) and Commercial Products.
- Support multifunctional teams to formulate plans and strategy that meets the defined objectives.
- Collaborate with R&D Drug Development iCMC IA packaging sites component material and equipment suppliers Regional Marketing Regulatory Supply Chain and QA in the development of project strategies and objectives.
- Lead or support the qualification (IOQ/PPQ) of process and packaging and primary and secondary equipment.
- Lead or support the qualification of transport systems for bulk / intermediates and finished products to established.
- Makes technical and businessbased recommendations on pharma and packaging processing supporting product development for both new and marketed pharmaceutical product projects.
- Develops test protocols and manages 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 multisite projects regarding technical documentation Define actives 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 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. Participate as an active member on: 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 Client.
- Bachelors Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering.
- Solid project management skills with varied scope and complexity with multifunctional/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 Guidances.
- 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.
- Required tools: strong project management experience; strong technical writing skills; proficiency with MS Office tools (e.g. responsibilities include authorship of Technical Packaging Reports).
- Soft skills: excellent English skills verbal and written (e.g. responsibilities include internal and external interactions with suppliers and customers technical discussions email presentations etc..
- 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 startup qualification and validation (Process and Packaging).
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
