Principal Technical Services Engineer, Blood Products

Date: May 11, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6234

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Blood Products Technical Services Engineer is responsible for maintaining manufacturing processes and systems from technology transfer throughout product commericalization and discontinuation.  The Technical Services Engineer has a strong understanding of Good Manufacturing Practices regulations and remains current on industry trends to ensure manufacturing processes and systems are aligned. The Technical Services Engineer will ensure approved products are compliant and maintained in a validated state through established processes (e.g. annual product review and change control).  The Technical Services Engineer has the responsibility to identify and resolve issues relating to manufacturing processes and systems (e.g. non-conformances, investigations, and CAPA).  

Principal Responsibilities

•    Remain current and thoroughly knowledgeable relative to the specifications, standards, and industry trends related to cGMP manufacturing and validation.
•    Receive the technology transfer of products from the product development team and partner with the product development team to ensure a seamless transition to commercialization.
•    Ensure that manufacturing operations are maintained in a validated state and in compliance with applicable regulatory requirements.
•    Provide technical support for Blood Product manufacturing operations to ensure quick resolution of issues related to process, product,equipment and facilities.
•    Create and revise documents (plans, protocols, reports, procedures, etc.) to document and execute necessary validation and qualification activities to maintain a validated state.
•    Create and revise supporting documents (procedures and forms) to ensure clear instructions and documentation for manufacturing operations.
•    Ensure existing facility, equipment and utilities are appropriately qualified, calibrated and maintained in a validated state to meet business needs.
•    Receive and maintain product and process risk management documentation.
•    Proactively identify risks to the organization. Clearly and concisely communicate risks and mitigation opportunities, strategies and costs to senior management.
•    Maintain appropriate cleaning validation, sterilization validation and environmental montoring programs.
•    Work with Medical Device Design Assurance Team to maintain an appropriate device history file as needed.
•    Work with Blood Product, Global IT and Software Validation Teams to ensure adequate system administration for validated computerized systems that are use for Blood Product commercialization.
•    Review and approve changes to existing processes, products, equipment and/or systems through change management process.
•    Maintain documentation to support all completed activities.
•    Communicate with stakeholders, internal and external, on outcomes in a timely manner
•    Provide technical support to contract manufacturers.
•    Supports Regulatory and/or other third party inspections.
•    Identify and lead continuous improvement opportunities to optimize existing processes and systems as agreed with management.
 

Education / Experience Requirements

•    Bachelor’s Degree required
•    >10 years of relevant experience required
 

Specialized Skills / Other Requirements

•    Proficiency with MS Office programs 
•    Good organizational skills and troubleshooting skills required
•    Ability to coach others and provide functional management to junior engineering staff
•    Understanding of GAMP5 guidelines prerfered
•    Strong understanding of Combination Products, Pharmaceutical, and Biologics cGMPs (21 CFR Parts 3.2(e), 4, 210-211, and 600-640)
•    Strong understanding of FDA Guidances for Industry 
 

 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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