Sr. Process Engineer - TS

Sr. Process Engineer - TS

Job Title:

Sr. Process Engineer, 3rd Party & Technical Services

Location:

Columbus, Ohio Job Type: Full time

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:

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.

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 stability; influence in establishing product specifications based on process and data trends. Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ. Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product filing (ANDAs, NDAs, PAS, CRLs, and other FDA correspondences) to support timely approvals.

Leverage lessons from registration scale batches and coordinate with Production/ Engineering team to drive procurement or modification of key manufacturing equipment to support commercial production. Lead the planning and execution of process transfers and scale-up/ evaluation, process validation/ PPQ and commercial production/ CPV of new and existing products (3rd Party/ CMO, Transfer (In/ Out) Buy-ins, Inter-site etc.) following Hikma requirements;

drive resolutions to complex process problems and influence teams to adopt solutions to meet commercialization/ product launch timelines/ deliverables. Lead as a process champion/ point of contact for process validation (process design, PPQ, & CPV) / commercial production at Hikma Lead proactive planning and strategies for the scale-up/ transfer/ validation lot manufacturing including commercial lot size determination, no. of lots for validation, documentation etc.

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