Barry-WehmillerPosted 1 month ago

Validation Engineer II

Barry-WehmillerPosted 1 month ago

On-siteIndianapolis, Indiana, United States

Indianapolis, Indiana, United StatesOn-siteFull TimeEnterprise

Full TimeEnterprise

Job Summary

Develop and execute validation and FDA compliance protocols for pharmaceutical equipment, including process equipment, utilities, and cleaning. Establish user requirement specifications, assess risks across system functions, and perform impact assessments and trace matrices. Collaborate with teams to investigate validation issues, analyze qualification data, and recommend corrective actions. Prepare validation reports, assist in project planning, and provide status updates to leadership and clients. Travel to support capital projects, assist in manufacturing process design, and manage facility development.

Required Qualifications

Minimum of 3 years project experience in the pharmaceutical or medical device environments
Strong technical writing and oral communications
Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
Willing and able to travel as necessary for project requirements to include but not limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
Understanding of ICH Q7 through 11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME2500
B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree
Ability to work as an individual contributor as well as a team player on a large project team
Candidates need to possess good communication and interpersonal skills
Flexibility with tasks and the ability to interact with all levels of management, clients, and vendors
Ability to effectively lead and coach others
Must be able to lift 50 lbs
Valid driver's license

Desired Qualifications

Experience with FDA compliance related documents/protocols for pharmaceutical equipment
Experience with Process Equipment, Facility / Utilities, Cleaning / Process
Experience with investigations and troubleshooting issues related to validation
Experience with qualification data analysis and corrective actions
Experience with impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverables
Experience with validation reports
Experience with project planning, scheduling, and coordination
Experience with routine communication and status updates to project leadership and the client
Experience with capital projects
Experience with implementing solutions for clients
Experience with making critical changes to improve performance and realize important goals
Experience with designing manufacturing processes
Experience with managing projects
Experience with developing facilities
Experience with conducting themselves with integrity in pursuit of individual and enterprise goals
Experience with being a passionate and successful business family member
Experience with expanding technical abilities
Experience with partnering with seasoned leaders, technical specialists, and subject matter experts
Experience with delivering the highest quality solutions to clients with consistency and accuracy
Experience with working with a team of industry experts
Experience with helping the world's leading companies solve their most difficult problems
Experience with supporting clients in realizing their most critical goals from Strategy to Commercialization
Experience with blending people-centric leadership with disciplined operational strategies and purpose-driven growth
Experience with building the future of manufacturing and technology
Experience with deep domain expertise in the manufacturing environment
Experience with an approach that is built to serve the dynamic needs of clients
Experience with being part of a committed team of over 1600 professionals
Experience with working in teams and directly with clients doing work that is shaping the world around us
Experience with being welcomed into a rapidly growing business and team
Experience with being empowered to make an impact
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with joining a team that will challenge you and position you for growth
Experience with working with a team of industry experts to help the world's leading companies solve their most difficult problems
Experience with joining the Regulatory Compliance Practice
Experience with partnering with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy
Experience with making an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment
Experience with being valued, cared for, and challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader
Experience with building a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools
Experience with being a world-class professional consultant
Experience with being a passionate and successful business family member
Experience with expanding your technical abilities
Experience with being challenged on your path to becoming a world-class professional consultant
Experience with being surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment

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