Engineer, Packaging

Job Title: Engineer, Packaging

Location: Columbus, OH

Job Type: Full-Time

Req ID: 11081

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 Engineer, Packaging to join our team.

In this role, you will be responsible, under the guidance of senior Packaging Engineers and management, manage and execute the lifecycle processes for all packaging components including troubleshooting and optimization to improve safety, quality, and efficiency on packaging lines.

Key Responsibilities:

• Represents Packaging Engineering Lifecycle Operations in the development and filing of new products, as needed, and collaborates with development partners (e.g. Technical Services) during commercialization batch production.
• Develops packaging material specifications for new or improved packaging components with input from senior Packaging Engineers.
• Prepares line trial protocols/reports, packaging material specifications, SAP master data, master packaging specifications, defines technical elements for product labeling, and complete other documents for assigned products/projects to meet established project timelines under the oversight of senior Packaging Engineers and management.
• Writes line trial reports that document technical packaging knowledge in a way that facilitates future decision-making regarding process optimization or troubleshooting (e.g. by Flow operations and/or Technical Flow); guidance from functional management and/or senior Packaging Engineers may be required to address significant process or equipment deviations (e.g. issues that may impact completion of the line trial or require commitment to post-line trial optimization activities or post-line trial monitoring).
• Provides review of new products / packaging regarding fit with operational capabilities (e.g. ability of components to run on a particular line, etc.), independently for processes of low to medium complexity (e.g. low complexity may be standard packaging components - bottle, cap, desiccant, cotton; medium complexity may be new components, new tooling, international Brand), and in consultation with senior Packaging Engineers and / or functional management for complex processes (e.g. powder filling, nasal sprays, cold chain], or processes with approaches rarely used (such as controlled atmosphere such as low relative humidity, glass vials, patches).
• Creates and reviews documentation (e.g. SAP Master Data, technical data, component specifications, Master Packaging Specification, eForms, technical elements for product labeling) for line trial and launch batch production, based on development packaging design parameters and product requirement considerations, in collaboration with development partners and senior Packaging Engineers.
• Ensures attention to detail to documentation to ensure quality and timeliness of documents.
• Collaborates with Purchasing and senior Packaging Engineers to source improved packaging components, if needed.
• If necessary, escalates to senior Packaging Engineers to analyze the data and determine path forward.
• Provides technical support to production, including assessment of non-standard events, implementation of troubleshooting next steps, and determination of product / packaging impact; provides recommendations for scenarios of low to medium complexity and business impact, and with moderate support from development partners, functional management, and/or senior Packaging Engineers for complex scenarios. Support will be required off-shift, including weekends, from time-to-time.
• Identifies product / packaging quality and packaging robustness optimization opportunities through analysis of product / packaging performance and collaboration with peer and customer groups (e.g. Physical Flow, Equipment Engineers, senior Packaging Engineers, PD, and QAI). Collaborates with organizational partners to support these initiatives, as necessary.
• Collects and analyzes Physical Flow packaging data. Evaluates trends and collaborate with Flow peers and management to identify and propose process improvements.
• After consultation with senior Packaging Engineers and management, collaborates with Drug Regulatory Affairs (DRA) to support assessment of the regulatory impact of potential packaging changes, documentation of implemented packaging changes, and ensure regulatory compliance.
• Collaborates with Change Management to support packaging and packaging component changes (e.g. CMU process).
• Shares and learns from best practices across the organization (PCs, Packaging Engineering Forums, etc.); shares observations from data reviews, highlight common errors, identify potential solutions to common errors, etc.
• Meets cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.

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:

• B.S. degree in Packaging Engineering, Industrial Engineering, or related scientific discipline
• Alternatively, higher degrees or additional related experience may be considered in lieu of the education or experience requirement listed above.

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.