Principal Engineer, Packaging - Technical Services

HIKMA•Columbus, OH

9d•Onsite

About The Position

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.

Requirements

B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 15 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or seven years of experience in product development, technology transfer, and/or packaging engineering in another technical field.
M.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 13 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or five years of experience in product development, technology transfer, and/or packaging engineering in another technical field.
Ph.D. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 10 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging or applicable pharmaceutical experience, or two years of experience in product development, technology transfer, and/or packaging engineering in another technical field. (Internship or co-op programs may qualify for work experience for those with Ph.D. degrees.)
Demonstrated ability to perform at expectations for the following Hikma competencies: Collaboration & Teamwork, Communication & Influence, Customer Focus, Planning & Organization, Taking Initiative & Drive For Results.
Expert knowledge and understanding of applicable laws and regulations regarding development and packaging of pharmaceuticals, including cGMP, DEA, and FDA guidances.
Demonstrated technical knowledge of pharmaceutical packaging environment and equipment with emphasis on scale-up/ optimization and validation for various dosage forms (e.g. modified/extended release, nasal suspensions, soft gels, bead/pellet coated products, film coated products, and/or novel delivery systems).
Subject Matter Expertise in experimental methodology and ability to design complex experiments to support pharmaceutical packaging development.
Ability to apply the PDCA principles (plan, do, check, act) and develop solutions for a variety of problems.
Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office (Work, Excel, PowerPoint, and Outlook) and SAP.
Strong ability to coach and/or mentor both in and out of reporting structure (e.g. mentoring junior Process Engineers, providing guidance to production Coaches and Technicians regarding optimization opportunities).

Nice To Haves

Proficiency in the use of statistical software for experimental design and analysis is preferred but not required.
10+ years commercial molding experience
Experience with systems such as SAP, TrackWise, Veeva or a Manufacturing Execution System (MES).

Responsibilities

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.