Job Title: Engineer II, Packaging
Location: Columbus, OH
Job Type: Full-Time
Req ID: 11082
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 II, Packaging to join our team.
In this role, you will be responsible to 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:
- Represent Packaging Engineering Lifecycle Operations in the development and filing of new products as needed and collaborate with development partners (e.g. Technical Services) during commercialization batch production.
- Develop packaging material specifications for new or improved packaging components.
- Prepare line trial protocols/reports, packaging material specifications, SAP master data, master packaging specifications, define technical elements for product labeling, and complete other documents for assigned products/projects to meet established project timelines.
- Write 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).
- Provide critical 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).
- Create and review 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.
- Ensure attention to detail to documentation to ensure quality and timeliness of documents.
- Collaborate with Purchasing to source improved packaging components, if needed.
- If necessary, escalate to senior Packaging Engineers to analyze the data and determine path forward.
- Provide technical support to production, including assessment of non-standard events, implementation of troubleshooting next steps, and determination of product / packaging impact; provide 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.
- Identify 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, Packaging Engineers, PD, and QAI). Collaborate with organizational partners to support these initiatives, as necessary.
- Collect and analyze Physical Flow packaging data. Evaluate trends and collaborate with Flow peers and management to identify and propose process improvements.
- Collaborate 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.
- Collaborate with Change Management to support packaging and packaging component changes (e.g. CMU process).
- Share best practices across the organization (PCs, Packaging Engineering Forums, etc.); share observations from data reviews, highlight common errors, identify potential solutions to common errors, etc.
- Meet 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 plus a minimum of two years' experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or other applicable pharmaceutical experience.
- Alternatively, higher degrees or additional related experience may be considered in lieu of the education or experience requirement listed above.
- Demonstrated knowledge of pharmaceutical production environment with emphasis on optimization
- Demonstrated technical knowledge of pharmaceutical packaging equipment.
- Knowledge of pharmaceutical packaging development.
- Exercises moderate latitude in determining objectives and approaches to assignments.
- Ability to be an active participant on teams of moderate to high complexity, and to lead/facilitate teams on tasks of moderate complexity.
- Skills to effectively educate colleagues on technical principles, process fundamentals, etc. (e.g. explaining critical packaging issues at PC meetings).
- Proficient knowledge and understanding of applicable laws and regulations regarding development and packaging of pharmaceuticals, including cGMP, DEA, and FDA guidance.
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.