Sr. Process Engineer - Technical Services

Title:

Sr. Process Engineer - Technical Services

Job Title: Sr. Process Engineer - Technical Services

Location: Columbus, Ohio

Job Type: Full time

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 continue to be 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 - Technical Services
.

In this role, you will be responsible for Leading the Registration/ Process Validation (Process Design, Process performance qualification, & Continuous Process Verification)/ Process transfer of in-house products (on-site development/ transferred or procured filings/ re-launch etc.) and champion cross coordination with multiple groups and alignment with Hikma’s quality/ compliance requirements. Leading the transfer of 3rd party/ CMO products (externally contracted for development/ manufacturing/ testing, Buy-ins, Site Transfers (in/ out), life-cycle) from R&D to Commercial Operations as a Process Champion from Hikma.

Developing and executing production strategies (e.g batch record documentation, GMP systems set-up etc.) for evaluation, scale-up, process validation, site transfer (in/out), and lifecycle products of multiple dosage forms (solids, non-solids, semi-solids, nasals, inhalation, etc.). Coordinating agency (e.g. FDA) submission documentation requirements, quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects. Mentoring junior process engineers and share best practices within Technical Services to continuously grow talent and enhance productivity.

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.

Qualifications:

• B.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of six (6) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or nine (9) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering.
• Alternatively, a M.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of four (4) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or seven (7) years of experience in another technical field in product formulation development, process…