Sr. Process Engineer - TS

Job Title:      Sr. Process Engineer, 3rd Party & Technical Services

Location:     Columbus, Ohio

Job Type:     Full time

Req ID:          11755

 

About Us: 

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them 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 Sr. Process Engineer, 3rd Party & Technical Services to join our team.

 

In this role, you will be responsible for the leads process validation, registration, and transfer for in-house and 3rd-party (CMO) products, ensuring alignment with quality and compliance standards. Oversees production strategies across multiple dosage forms from development through commercialization, including scale-up, validation, and lifecycle management. Coordinates regulatory submissions, process changes, and cross-functional activities while mentoring junior engineers and promoting best practices.  Leads process development, validation, and transfer for in-house and third-party (CMO) pharmaceutical products. Acts as a technical expert to ensure successful product scale-up, regulatory compliance, and commercialization across multiple dosage forms.

 

Key Responsibilities:

1. Consult as Process and Formulation Champion on cGMP/ FDA/ Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/ scale-up/ validation and commercial production for 3rd Party/ CMO & in-house products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase.

• Lead as Hikma’s Technical Services representative for in-house process flow & equipment requirements for different products (solids, non-solids, nasals, inhalation, etc.) and spearhead 3rd Party/ CMO site visits, process and equipment requirements, and other technical considerations during project selection, and execution.
• Drive gap and risk assessments including statistical data analysis for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities.
• Lead strategy development for filing and validation (e.g. lot sizes, number of lots, sampling plan etc.) and drive requirements (e.g. protocols, batch records, etc.) for registration scale-up, evaluation, transfer, and process validation batch production.
• Create and/ or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.), and master data for production of batches for registration/ filing/ scale-up, evaluation, and process validation
• Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during registration/ evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and technical support on process and quality requirements of Hikma to mitigate risks during commercial production.

1. Lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma to establish robust control strategy for future commercial process.

• Collaborate with stakeholders (e.g. Product Development, Production etc.) during development, pilot lot production, registration, etc. to optimize or develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks. 
• Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stabil