Job Title: Process Engineer
Location: Columbus, OH
Job Type: Full-Time
Req ID: 10907
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 750 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 8,500+ 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 Principal Process Engineer to join our team. In this role, you will be responsible for s upporting continuous improvement through process optimization of assigned Flow (e.g., product
lifecycle management, process troubleshooting, yield improvements) and engagement with various Performance Centers, while ensuring compliance with government regulations and Hikma standards. Implements innovative new process, technology, quality, and compliance approaches (e.g., CIA and CAPA) at Hikma.
Key Responsibilities
- Regular and predictable onsite attendance and punctuality.
- Manages the lifecycle of launched products on an assigned basis to support development of robust manufacturing processes, drives site right-first time metrics, and reduces product rejects.
- Seeks out and identifies some process optimization opportunities, as well as pursues opportunities identified by others. Performs appropriate assessment of risk versus benefit, participate in cross-functional assessments as required to evaluate opportunities, and implement improvements.
- Collaborates with Flow Supervisors to drive shared business ownership and continuous improvement, particularly in regard to process performance (Zero Defects, RFT, Throughput Time, Physical Yield, etc.).
- Partners with peers (e.g., Flow Supervisors, Production Engineers, Packaging Engineers, and QA Investigators) to support root cause analysis and CAPA review; supports assigned Flow in the assessment / investigation and remediation of deviations and atypical events. Facilitates closure of deviations and ensure actions are taken to prevent recurrence.
- Seeks out and identifies CAPA opportunities, as well as pursue opportunities identified by others. Evaluates opportunities for impact, cost effectiveness, and scope (e.g., applicability to other Flows and/or other Hikma sites).
- Provides first-line troubleshooting for process-related issues, responding with appropriate analysis, impact assessment, and path forward determination. Leverages troubleshooting and investigation experiences as opportunities to engage with the CAPA process.
- Advances the development of Performance Centers through the collection and analysis of Key Performance Indicators, supports Technician improvement ideas (CIA), and facilitates improvement ideas elevated to the Area Performance Center.
- Partners with peers (e.g., Flow Supervisors, Production Engineers, and Packaging Engineers) to identify process issues and implement sustainable solutions within assigned Flow and technologies, aligned with Site Metrics, Business Objectives and Site Strategy.
Qualifications
- B.S. in Biology, Chemistry, Engineering, Pharmacy, or related scientific discipline, plus a minimum 2 years of pharmaceutical experience, or a minimum of 8 years of pharmaceutical experience, in an area that provides a knowledgeable background in pharmaceutical technology transfer, quality assurance, quality control, product development, or manufacturing.
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.
