Process Engineer/Transfer - Technical Services - 7321

Job Title: Process Engineer, Process Transfer – Technical Services

Location: Columbus, OH

Job Type: Full time

Req ID: 7321

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Process Engineer, Process Transfer – Technical Services to join our team.  In this role, you will be responsible for transferring products of varying types (Generic commercialization, Site Transfers, Buy-ins, Third Party & key lifecycle (Alt. API) from R&D or applicable partner to Operations, including supporting process development and registration, performing scale-up / validation, site transfer, start-up of commercial production, and transfer to lifecycle support.  Minimize obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D, Supply Chain, and Operations colleagues.  

 

Key Responsibilities:

• Collaborates with development partners/customers during the process development and registration of new product NDAs, ANDAs, and / or site transfers, ensuring that all project timelines are met.   

• Represent Process Transfer Technical Services and Operations in the development and filing of new products.

• Collaborate with development partners (e.g. Product Development) during development and pilot scale batch production.

• Provide critical review of new products/processes regarding fit with operational capabilities (e.g. batch sizes vs. equipment capacity, and technical challenges of the product/process such as poor flow, segregation, or batch splitting, etc.), independently for processes of low to medium complexity (e.g. low complexity may be direct blend or bin-mill-bin processes; medium complexity may be roller compaction or fluid bed granulation processes without any particular difficulties), and in consultation with functional management and /or Senior Process Engineers for complex processes (e.g. roller compaction or fluid bed granulation process with difficult formulations [due to API sensitivities, poor flow properties, etc.], or processes with approaches rarely used at Hikma, such as top spray granulation or inclusion of API in the granulating solution). 

• Provide feedback to product development or partners on potential critical mismatches between new products/processes and operational capabilities, identify potential non-critical process optimization opportunities.

• Collaborate with product development or partners in the selection and/or design of processes and systems which meet product and regulatory requirements, and are compatible with our manufacturing practices, while meeting marketing and financial needs.  May require assistance from functional management or Senior Process Engineers to influence development partners in the selection of processes and/or systems.

• Create documentation (e.g. SAP Master Data, PMX production procedures, registration batch lot records) based on process design parameters (e.g. formulation and processing steps) mutually agreed upon with product development partners.

• Collaborate with product development or partners to drive shared business ownership and continuous process improvements, particularly in regards to process performance (Zero Defects, RFT, Throughput Time, Physical Yield,