Principal Engineer, Packaging - Tech Services jobs in United States
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Hikma Pharmaceuticals · 1 week ago

Principal Engineer, Packaging - Tech Services

Hikma Pharmaceuticals is a developer, manufacturer, and supplier of essential medicines committed to making high-quality medicines accessible. They are seeking a talented and motivated Principal Engineer, Packaging – Technical Services to lead packaging development, ensure project timelines are met, and support product transfer and commercialization processes.

Health CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Pharmaceutical technology transferPackaging engineering expertiseRegulatory submission documentsCGMPDEAFDA regulationsStatistical software proficiencyMentoring / CoachingCommunication & InfluencePlanning & OrganizationTaking Initiative & Drive For ResultsComplex Problem SolvingComputer SkillsCollaboration & TeamworkCustomer FocusCritical Thinking

Required

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.)
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)
Experimental Methodology: Subject Matter Expertise in experimental methodology and ability to design complex experiments to support pharmaceutical packaging development
Critical Thinking/Complex Problem solving: Ability to apply the PDCA principles (plan, do, check, act) and develop solutions for a variety of problems
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) and SAP
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

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

Benefits

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.

Company

Hikma Pharmaceuticals

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Hikma focuses on a wide range of generic, branded generic and in licensed pharmaceutical products

H1B Sponsorship

Hikma Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (23)
2023 (22)
2022 (24)
2021 (28)
2020 (18)

Funding

Current Stage
Public Company
Total Funding
$250M
Key Investors
International Finance Corporation
2025-07-15Post Ipo Debt· $250M
2005-11-04IPO

Leadership Team

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Said Darwazah
Chief Executive Officer
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Khalid Nabilsi
Chief Financial Officer
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Company data provided by crunchbase