Materials Engineer III

Posting Date 2 months ago(3/21/2022 8:32 AM)
Requisition ID
2022-10509
Job Location(s)
Pittsburgh PA United States
Travel
10-20%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Purchasing/Supply Chain

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Materials Engineer III at Cook MyoSite Inc. is responsible for being the subject matter expert on materials and their impact to the process or the product through assessment of the material attributes.

Responsibilities

• Complete scientific analysis for identification of new & alternate material sources
• Serve as a technical point of contact for collaboration with vendors, AMD, PD, PE, PN
• Drive timing of enrollment by collaboration with internal/external partners
• Develop proactive plan for evaluation of materials
• Determine impact to product or process for change notifications
• Identify new and alternative material sources
• Provide technical support for material investigations and audit findings as necessary
• Collaborate on material testing requirements
• Evaluate and verify shelf-life integrity
• Active participation within the Material Review Board
• Determine material attributes and how they impact process or product
• Assess materials for secondary and tertiary sources
• Design experiments associated with the determination of material usage
• Provide technical guidance when needed on process owned materials
• SME for any decisions associated on how material will impact process or product
• Provide guidance for other departments on priority and timelines for material related needs
• Act as a resource to provide technical and scientific troubleshooting support to company departments, as needed, in area(s) of expertise
• Provides support as the process material SME in the evaluation and transfer of new technology and processes
• Works with department management to identify and develop objectives and timelines in support of new and ongoing material projects
• Where needed, develops scientific and technical expertise and capabilities as necessary for project completion
• Prepares technical and scientifically accurate reports and presentations for internal and external use
• Performs research, analyzes, and summarizes data, participates in the interpretation of results and formulation of appropriate recommendations
• Effectively tracks and communicates with department management regarding project progress and milestones via regular meetings, scientific presentations and/or written reports

Qualifications

• Undergraduate degree in any Life Sciences or Engineering or 6 years direct, relevant experience in the Bio-pharmaceutical industry to provide a comparable background

• Minimum of 3-6 years' experience in the biopharmaceutical or healthcare industry is highly preferred

• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

 

Physical Requirements:

• Office Setting (with travel): General office, warehouse and laboratory setting.

• Travel (Domestic & International): 20-30%

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

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