Principal Engineer, Packaging - Tech Services

Title:

Principal Engineer, Packaging
- Tech Services

Job Title: Principal Engineer, Packaging
- Tech Services

Location: Columbus, OH

Job Type: Full time

Req : 8920

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.

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 Engineer, Packaging – Technical Services to join our team.

In this role, you will be responsible for transferring products [(Generic commercialization, Site Transfers, Buy-ins, Third Party & key lifecycle (Alt. API)] from R&D or partners to Operations, including leading packaging development, registration, site transfers, start-up of commercial production, and transfer to lifecycle support. Minimize and remove obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D, Operations, and external colleagues.

Support department management as group representative in technical and business meetings. Act as a technical subject matter expert and mentor for the Technical Services group and the site.

Demonstrate influence, leadership, and influential teamwork skills with development partners/customers during the packaging development and registration of site transfers and new product NDAs and ANDAs, ensuring that all project timelines are met.

• Provide packaging engineering expertise , i.e. critical review, assessment, influence and strategy, for responsible projects assigned within Organic Launch, Business Development, Contract Manufacturing Organization (CMO), Alternate API, and targeted dormant products.
• Create all associated master data for assigned projects.
• Create all associated structure technical data for assigned projects.
• Create all specifications required for the container/closure systems for assigned projects.
• Create all associated aggregation/serialization requirements for assigned projects.
• Attend all required team meetings to support assigned projects and ensure to achieve key milestone datas.
• Perform all necessary line trials, including all necessary documentation such as protocols/reports/PO’s, to support proper evaluation of form, fit, function of proposed container closure systems.
• Support all regulatory audits as required.
• Generate all required regulatory submission documents for assigned projects and provide support in generating responses to regulatory authorities.
• Support other Technical Service Packaging Engineers with peer review; as well as, provide appropriate mentoring.
• Influence and Collaborate with Purchasing to source new packaging components, if needed.
• Interact with outside vendors to design new packaging components.
• Influence and Liaise with Change Management to support packaging component changes.
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Influence and Liaise with Flow Packaging group to ensure consultation of launch projects for efficient transfer of applicable projects for life cycle transfer.
• Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Operations.

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:

• B.S. degree in…