Enterprise Architect

Posting Date 3 weeks ago(5/23/2021 11:36 AM)
Requisition ID
2021-9049
Job Location(s)
Pittsburgh PA United States
Travel
10-20%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Information Technology

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 Enterprise Architect at Cook MyoSite is responsible for incorporating life sciences subject matter expertise (SME) with Information Technology and Information Systems expertise. For computerized systems serving the enterprise, the Enterprise Architect is accountable for the architectural roadmap, responsible for integration planning, and responsible for designs supporting data integrity of computerized systems serving the enterprise.

Responsibilities

• Propose and define technology solutions based on user/client needs, cost, data integrity needs, and required integration
• Serve as a Life Sciences SME for computerized systems, including instrumentation systems and environmental systems driven by computerized systems; author system delivery strategies, functional and integration specifications, and design documents
• Lead new technology feasibility studies and demonstrations to drive technology to meet user/client needs
• On an on-going basis, review existing computerized systems for meeting Key Performance Indicators (KPIs), Quality Metrics (QMs), and data integrity by monitoring performance verse those parameters and providing technology proposals and corrective actions when not met
• Initiate and drive activities with external consultants to drive technology to meet user/client needs
• Drive and lead cross-functional activities to ensure business unit activities are coordinated with technology initiatives
• May indirectly supervise team members; including supporting personnel development to ensure essential job functions and duties are performed at high standards
• Create and review Business and Standard Operating Procedures (BOPs and SOPs) and training materials
• Practice and stay current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies

Qualifications

• Bachelor's degree in Bio-Engineering, Life Sciences, Computer Science, or Information Systems or 6 years direct, relevant experience in industry related experience relevant to life sciences and information technology systems to provide a comparable background

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices

• Minimum of 3-6 years' of industry experience relevant to life sciences and information technology and systems preferred
• Minimum of 3-6 years' experience in software programming experience on enterprise computerized systems, developing formal specifications to standards and best practices, and working with systems in a manufacturing or laboratory environment preferred
• Up-to-date with changes in technology and the business implications/applications of new technologies
• Proficiency or comfort level working with material of a highly technical or scientific nature

• Demonstrable knowledge of architecture for computerized systems; certifications preferred
• Demonstrable ability to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations; ability to use that information to provide innovative enterprise solutions preferred

 

Physical Requirements:

• 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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