Process Engineer

Title: Process Engineer II

Location: Morristown, NJ

Duration: 12 Months Possible Extension

Fully onsite

Notes:

• Traveling for the Contingent Worker: We currently have a project that might require travel to Toronto, Canada.
• Additionally, there might be a need for domestic (US) or European travel based on departmental needs.
• Typically, this involves one week of travel, sometimes leaving on Sunday and returning on Saturday, depending on the manufacturing schedule.
• If the travel is to the EU, we will typically leave the US two days before the production start and leave soon after.
• Required travel to Toronto location for process support, estimated 2-3 times per year (1 week at a time) Open to those willing to relocate at own expense, however local candidates preferred

Must have Skills:

• Bachelor's Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering • Will accept candidate with MS, PHD Degrees
• Minimum years of 5 years of experience in similar role
• FDA and EMA Regulations
• Process Engineer for liquid formulation
• Strong technical writing experience, ability to write reports, protocols
• Biotech and Pharma experience
• Reimbursement will be provided for travel & Some OT during traveling
• Nice to Have:
• Packaging experience, knowledge: USP, ASTM, ISTA, IATA, CFR, and FDA Guidance’s

Description:

Mission

• Support activities within MSAT-US regarding technical documentation, SOP’s, 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 multi-functional 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.

Duties & 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 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.

Knowledge, Skills & Competencies/Language

• Solid project management skills with varied Product 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’s.

• 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, e-mail, 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 start-up, qualification, and validation (Process and Packaging).

Qualifications

• Bachelor's Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering