Sr Biological Process Development Engineer
Teleflex

Job Info

Expected Travel: None

Requisition ID: 4628

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.

US COVID-19 Vaccination Requirements

Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.

Employees and new hires in sales or field-based roles that require vendor credentials to access medical facilities as an essential function of the job, may be required to obtain the COVID-19 vaccination based on customers/site requirement. This requirement is independent of Teleflex policy or any applicable US governmental regulations.

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

• Developing and documenting manufacturing processes capable of producing pharmaceutical/biological products to meet established design specifications and cost targets in a timely and efficient manner.
• Planning, coordinating, and executing process validations and transfer validated processes and equipment into production for commercial manufacturing.
• Identify, specify, and coordinate development and sourcing of equipment, tooling, fixtures and component materials to produce product per design specifications

Principal Responsibilities

• Execute process characterization and investigations to establish process limits
• Plan process development & validation activities for new products based on; projected product volume, project timelines, and COGS targets
• Lead deveopment of manufacturing processes for new product from benchtop scale to commerical scale using Quality by Design approach (ICHQ8)
• Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader
• Generate documentation as outlined in the Process development process (e.g. FMEAs , protocols, reports, manufacturing records, and design transfer reports)
• Direct PD technicians on creation of equipment files (IQP, test execution, and IQR), and completion of characterization and qualification builds
• Conduct thorough analysis of test data including: identification of outliers or non-normal data, generating data regression and factorial designs, general statistical analysis, and determining process capability
• Conduct thorough Failure Analysis and Root Cause investigation and report results
• Train PD technicians, production operators and manufacturing technicians
• Identify, propose, and pursue COGS reduction and/or quality improvement opportunities which align with company business objectives
• Coordinate, direct, and execute systematic process development activities such as; process characterization, DOE (to establish process limits), qualification and validation builds
• Design and develop process flow and lay out to maximize production efficiency
• Mentor PD Technicians junior engineering staff
• Conduct process design, development, and implementation on multiple complex &/or significant company projects
• Identify and pursue systemic improvement opportunities to maximize efficiency

Education / Experience Requirements

• BA/BS in chemistry, biochemistry, chemical engineering, or related science with a minimum of 5 years of biotechnology or pharmaceutical related process development experience.
• Experience with processes or methods used in the pharmaceutical or biotechnology industry; FDA regulated industry experience

Specialized Skills / Other Requirements

• Must possess the ability to understand, follow, and improve VSI documentation and quality system
• Demonstrated project management skills and ability to coordinate multiple projects simultaneously
• Demonstrated understanding of and capability to perform process qualification and validation activities
• Ability to organize, direct, and perform Process Validation activities including QbD, DOE, statistical analyses, process capability analyses and make data driven process decisions/determinations
• Leadership skills to train and mentor less experienced engineers
• Familiarity with Quality System methodologies and regulations associated with pharmaceutical and medical device industires
• Basic resource and budgetary planning skills

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.

© 2021 Teleflex Incorporated. All rights reserved.