Device Assembly & Packaging Engineer

The Technical Services and Manufacturing Sciences (TSMS) Device Assembly and Packaging Engineer will be responsible for supporting device assembly and packaging development across all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide technical support for secondary manufacturing operations to ensure robust and reliable packaging and device assembly processes are established and executed.

This position will support the delivery of technical guidance and assistance throughout packaging and device assembly processes. The primary objective is to assist with establishing secondary manufacturing processes for autoinjectors and complex packaging systems that consistently deliver high-quality combination products from clinical through commercial manufacturing.

Essential Job Functions:

• TSMS Device Assembly and Packaging Engineer is responsible for the execution of early packaging and/or device assembly development activities in a cross-functional team and requires pharmaceutical packaging and combination product development knowledge. You will be responsible for the development of primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization.
• Meet with client team to understand packaging requirements and develop technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA.
• A solid understanding of combination devices (auto injectors), packaging materials and manufacturing processes and experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products is required.
• Assists technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
• Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the device assembly and packaging processes.
• Help authoring GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
• Monitor Process Data, identify trends and propose actions as necessary.
• Other responsibilities as required.
  
  
  

Special Job Requirements:

• Bachelor’s degree in science, engineering or packaging technology.
• Master’s degree in science, engineering or packaging technology preferred.
• Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization.
• Experience in global product launches and the associated CMC regulatory requirements.
• Understanding of regulatory device requirements (DHF, RMF, Design Inputs, Design Outputs, Design Transfer).
• Minimum 1 year of GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.
• Functional knowledge of regulatory requirements and industry guidance applicable to CGMPs for Combination Products, including 21 CFR Part 4 Regulation of Combination Products and FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016 Medical devices — Quality management systems.
• Awareness of industry trends and best practices, current regulatory landscape including FDA actions/activities, and advanced regulatory requirements and industry guidance applicable to CGMPs for Combination Products including EU Medical Device Regulation (EU MDR 2017/745) and ISO 14971:2019 Medical devices — Application of risk management to medical devices.
• SME on risk management and validation of medical devices.
  
  
  

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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