Hikma Pharmaceuticals

Job Title: Principal Engineer, Packaging – Tech Services

Location: Columbus, OH

Job Type: Full time

Req ID: 8920

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines 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 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.

Key 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.

• Represent Technical Services in the development and filing of new products.
• Influence and Collaborate with Purchasing to source new packaging components, if needed.
• Interact with outside vendors to design new packaging components.
• Develop packaging material specifications for new packaging components for internal projects (R&D) and external customers (BD, transfers).
• Provide independent critical review of new products / packaging regarding fit with operational capabilities (e.g. ability of components to run on a particular line, etc.) for processes of all complexity levels, informing functional management and other Packaging Engineers (best practice sharing) about challenging packaging processes (e.g. powder filling, nasal sprays, cold chain), or processes with approaches rarely used at West-Ward (such as controlled atmosphere such as low relative humidity, glass vials, patches). Particularly challenging packaging may require consultation with senior Packaging Engineers or functional management to collaboratively develop solutions (i.e. titration packs, spoons).
• Provide feedback to product development or partners on potential critical mismatches between new products/packaging designs and operational capabilities, identify potential non-critical packaging optimization opportunities, and identify operational best practices that may influence packaging design parameters.
• Lead and Influence product development or partners in the selection and/or design of packaging which meet product and regulatory requirements, and is compatible with our packaging practices, while meeting marketing and financial needs.
• Create documentation (e.g. SAP Master Data, non-commercial component specifications, non-commercial Master Packaging Specification) based on process design parameters (e.g. formulation and requirements of the product) mutually agreed upon with product development or partners.
• Perform peer review of documentation to drive right-first-time performance of department and to ensure accuracy of PE documentation that is delivered to customers (e.g. component specifications, Master Packaging Specifications, submission documentation, etc.).
• Execute assigned project deliverables with limited to no consultation with functional management and/or senior Packaging Engineers for highly complex challenges; can execute most project deliverables independently but may require consultation on technical aspects for packaging projects of high complexity outside of previous experience.
• Drive highly effective Risk Assessment processes at applicable development and launch gates, in collaboration with product development or partners; identify and escalate critical risk areas, and propose remediation plans to address them.
• Drive mitigation of risks as identified in Risk Assessment, and influence development partners to mitigate risks still under development control.
• Influence and Liaise with Drug Regulatory Affairs (DRA) to support documentation required for product filing or deficiency responses; prepare packaging documentation for submission per Corporate Guidelines.
• Influence and Liaise with Change Management to support packaging component changes.
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Act as a technical subject matter expert for Technical Services group and the site

Leads Packaging Risk Analysis and Line Trials for new products (Generic, Site Transfers, Buy-ins, and Third Party) as the Technical Services representative, and influences development and Hikma partners to ensure that new products meet requirements for quality, cost and manufacturability.

• Collaborate with and influence product development or partners during site transfer, scale-up and validation production and packaging to ensure all applicable launch deliverables are met and to identify and plan for post-launch optimization opportunities.
• Influence and Liaise with Flow Packaging group to ensure consultation regarding launch projects, to enable efficient transfer of products to lifecycle support.
• Create documentation (e.g. SAP Master Data, Packaging Record, Line Trial Protocols) for scale-up, evaluation, and validation batch production, and best practices, as mutually agreed upon with development partners.
• Provide around-the-clock technical support to production, including assessment of non-standard events, implementation of path forward (e.g. Request for Technical Service), and determination of product impact; provide recommendations for scenarios of all levels of complexity and business impact, keeping functional management and other Packaging Engineers informed (best practice sharing) about resolution of highly complex processes.
• Execute assigned project deliverables with limited to no consultation with functional management for highly complex challenges; can execute most project deliverables independently, but may seek consultation/second opinion on technical aspects of processes of high complexity outside of previous experience.
• Lead functional and cross-functional investigations to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs. Influence organizational partners to support these initiatives, as necessary.
• Drive packaging, process, and specification improvements; implement cost reduction initiatives such as different packaging components or packaging design; and participate in project or issue based teams.
• Influence and Liaise with Change Management to support packaging changes with impact assessment on finished dosage forms.
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Act as a technical subject matter expert for the Technical Services group and the site.

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 to support product launches / qualification.

• Drive line trial strategies and documentation (e.g. protocols) with limited to no consultation based on standard approaches modified as necessary based on critical packaging configuration reviews, experience, and decision-making skills; if project needs require, propose alternative approaches, along with justification for the approach. Particularly challenging packaging configurations may require consultation with functional management to collaboratively develop solutions.
• Support Process Technical Services in the creation and review of packaging related portions of protocols and reports to support product commercialization / qualification.
• Ensure attention to detail to documentation to ensure quality and timeliness of documents.
• Perform peer review of documentation to drive right-first-time performance of department and to ensure accuracy of PE documentation that is delivered to customers (e.g. component specifications, Master Packaging Specifications, submission documentation, etc.).
• Execute assigned project deliverables with occasional consultation with functional management and/or senior Packaging Engineers for highly complex challenges; can execute most project deliverables independently but may require consultation on technical aspects of processes of high complexity outside of previous experience.
• Lead best practices regarding documentation (including line trial strategy & protocol development and line trial report documentation) across the organization.
• Prepare Packaging Documentation for submission per Corporate Guidelines.
• Influence and Liaise with Flow Packaging group to ensure consultation of launch projects for efficient transfer of applicable projects for life cycle transfer.
• Influence and Liaise with Change Management to support packaging changes with impact assessment on finished dosage forms.
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Provide audit support as needed during varying customer / agency site audits
• Act as a technical subject matter expert for the Technical Services group and the site.

Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Operations.

• Identify and prioritize product quality and process robustness optimization opportunities through analysis of product/process performance and collaboration with peer and customer groups (e.g. Physical Flow, Equipment Optimizers, Process Optimizers, Purchasing, business partners, PD, and QAI). Influence organizational partners to support execution of these initiatives.
• Lead functional and cross-functional investigations to determine root causes, assess product impact, determine path forward, and develop/implement CAPAs. Influence organizational partners to support execution of these initiatives.
• Seek out technical solutions to improve performance including collaborating with internal and external experts.
• Influence and Liaise with Change Management to support process and raw materials changes.
• Influence and Liaise with Drug Regulatory Affairs (DRA) to support assessment of the regulatory impact of potential packaging changes, documentation of implemented process changes, and ensure regulatory compliance.
• Provide around-the-clock technical support to production, including assessment of non-standard events, implementation of path forward (e.g. Request for Technical Service), and determination of product impact; provide recommendations for scenarios of all levels of complexity and business impact, keeping functional management and other Packaging Engineers informed (best practice sharing) about resolution of highly complex processes.
• Execute assigned project deliverables with limited to no consultation with functional management and/or senior Packaging Engineers for highly complex challenges; can execute most project deliverables independently but may seek consultation/second opinion on technical aspects of processes of high complexity outside of previous experience.
• Transfer launched products to lifecycle support with Operations, per established processes; transfers are executed independently, without need for functional management to facilitate transfer, although consultation may be required for highly complex processes or products with a history of manufacturability challenges.
• Lead best practice sharing and implementation across the organization (PCs, Optimizer Forums, Process Engineering Forums, etc.).
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Provide audit support as needed during varying customer / agency site audits
• Act as a technical subject matter expert for the Technical Services group and the site.

Mentor and develop other members of the Technical Services department. Act as a subject matter expert on core technologies and/or packaging engineering topics (e.g. particular pieces of equipment, statistical analysis, validation approaches, etc.).

• Lead knowledge sharing, individual skill development, and career development within the department, through sharing and implementation of best practices in both individual and group settings (e.g. 1:1 mentoring regarding a specific product/process challenge, and in PC meetings/staff meetings, respectively).
• Identify and proactively create opportunities to mentor junior Packaging Engineers on specific equipment and process technologies (e.g. bringing junior Packaging Engineers to the shop floor during production and/or troubleshooting support), and on technical problem solving (e.g. after identifying trends of potential concern during peer review of a junior Process Engineer's project, provide mentoring on recommend approaches for analysis and remediation, if needed).
• Identify and proactively create opportunities for junior Packaging Engineers to engage in job shadowing with senior Packaging Engineers to learn systems, processes and procedures, and technical aspects of equipment and unit operations to increase proficiency.
• Maximize resource utilization and department capabilities by increasing technical capabilities in junior Packaging Engineers. (Refer to above bullet points.)
• Lead skill development of junior Packaging Engineers in the 5 Performance Standard competencies of Collaboration & Teamwork, Communication & Influence, Customer Focus, Planning & Organization, and Taking Initiative & Drive For Results.
• Lead by Example when representing Technical Services group in technical or business meetings.
• Act as a technical subject matter expert for the Technical Services group and the site.

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 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.
• Alternatively, a 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.
• Alternatively, a 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.)
• Expert knowledge and understanding of applicable laws and regulations regarding development and packaging of pharmaceuticals, including cGMP, DEA, and FDA guidances.
• Demonstrated knowledge of pharmaceutical packaging environment with emphasis on scale-up/ optimization and validation.
• Demonstrated technical knowledge of pharmaceutical packaging equipment.
• Demonstrated knowledge of packaging development.
• Subject Matter Expertise in pharmaceutical packaging technologies.
• Expert in knowledge of pharmaceutical packaging development, technology transfer, or production principles and practices. Ability to successfully develop and/or transfer pharmaceutical packaging processes for challenging dosage forms and/or processes (e.g. modified/extended release, nasal suspensions, soft gels, bead/pellet coated products, film coated products, and/or novel delivery systems).
• Demonstrated ability to perform at expectations for the following Hikma competencies: Collaboration & Teamwork, Communication & Influence, Customer Focus, Planning & Organization, Taking Initiative & Drive For Results.
• Experimental Methodology: Subject Matter Expertise in experimental methodology and ability to design complex experiments to support pharmaceutical packaging development. Proficiency in the use of statistical software for experimental design and analysis is preferred but not required.
• Critical Thinking: Ability to apply the PDCA principles (plan, do, check, act).
• Complex Problem Solving: Expert knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. Uses problem solving abilities requiring attention to detail, accuracy, and scientific judgment. Develops solutions to a variety of problems of high scope and complexity, as defined in Accountabilities section.
• Mechanical and technical aptitude: Expert knowledge of the functionality and troubleshooting of pharmaceutical packaging equipment, and understanding of the impact of critical equipment parameters on key product performance parameters at the expert level.
• Production and Processing: Technical knowledge and expertise to effectively lead product development activities for packaging related items.
• Computer Skills: 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).
• Project Management: Experience managing and leading project specifics aspects to packaging and/or process improvements teams of high scope and complexity.
• Initiative: Works with no to limited supervision for both for strategic decisions and tactical execution of tasks of high complexity. Exercises latitude in determining objectives and approaches to assignments.
• Teamwork: Demonstrated ability to be an influencing participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity.
• Training: Skills to effectively educate colleagues on technical principles and process fundamentals related to packaging etc. (e.g. explaining critical process issues at PC meetings).
• Mentoring / Coaching: 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).

Preferred Qualifications:

• 10+ years commercial molding experience
• Experience with systems such as SAP, TrackWise, Veeva or a Manufacturing Execution System (MES).

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave
• Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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.