Sr. Engineer, Combination Products & Medical Device

Job Title:

Sr. Engineer, Combination Products & Medical Device

Location:

Columbus, OH

Job Type: Full time

Req

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them 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 Sr. Engineer, Combination Products & Medical Device to join our team.

In this role, you will be responsible for providing Combination Product and Medical Device Quality System Framework and Design expertise both within local operations and to drive best practices within the global organization.

Support includes ensuring that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site.

Responsibility also includes assessing, evaluating, identifying and implementing required documentation and studies to support requirements for launch, lifecycle changes and Business Development opportunities to meet identified business objectives and targets.

Key Responsibilities:

Knowledge Management

* Stay up to date on regulations and regulatory trends to ensure that practices and procedures remain current with regulatory health authorities' expectations with regards to Combination Products and Medical Devices i.e. 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO
14971, etc…

* Supports Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed

* Active member of relevant industry groups and key stakeholder organizations

* Direct the work of consultants as needed and mentor others

* Responsible for driving site education with regards to combination products and medical device requirements and organizational processes.

Infrastructure Support

* Develop and ensure lifecycle management of a Quality Management System to be compliant with all relevant combination product and medical device regulations

* Work within a Center of Excellence to share and align on best practices across Hikma Operating Units

* Facilitate and/or supports the development and implementation of combination product and medical device quality governance processes and procedures

* Develops and drives Risk Management approach

* Contributes in relevant Quality Governance meetings

Project Support

* Leads and/or participates on departmental and/or cross-functional teams as Combination Product and Medical Device SME

* Performs gap assessments of processes and procedures against relevant device regulations

* Develops recommendations and proposals to address identified gaps and provides expert guidance for projects

* Drives, as appropriate, key activities such as risk analysis, FMEA and threshold analysis for active projects

* Drive required Statements of Work with consultants where needed to support specific product programs e.g. device reliability, human factor studies, threshold analysis, FMEA, and/or risk analysis

* Drives change control support for Combination Product & Medical Device requirements assessment and deliverable review

* Provide support for relevant investigations and CAPA(s)

* Provides guidance on approach and regulatory responses support for health authority questions to support product approvals

* Other duties as assigned

* Predictable, consistent onsite attendance required

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. in engineering field (e.g. pharmacy, chemical, medical device, packaging or mechanical) with 10+ years direct experience at a medical device manufacturer or combination product manufacturer

* M.S. in engineering field with 5+ years direct experience at a medical device manufacturer or combination product manufacturer

Business & Technical Expertise

* Strong understanding of business development, lifecycle management, and long-term planning.

* Subject matter expert in combination products and medical devices, including design controls, risk management, validation, reliability, and process controls.

* Deep knowledge of pharmaceutical principles and complex dosage forms (e.g., nasal suspensions, dry powder inhalers, novel delivery systems).

* Experienced in manufacturing,…