Sr. Process Engineer - Technical Services

Job Title : Sr. Process Engineer - Technical Services

Location : Columbus, Ohio

Job Type : Full time

Req ID : 9740

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 :

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.

2. 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.

3. 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.

4. Mentor and develop other members of the Technical Services department and promote knowledge transfer within Technical Services. Act as a subject matter expert on core technologies and / or process engineering / validation topics.

Qualifications :

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them :

What We Offer

Recruiters :

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer :

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Location :