- Deliver Commissioning and Qualification (C&Q) solutions and services for client facility, utility, process, and equipment
- Develop and execute a variety of validation and FDA compliance related documents/protocols
- Author specifications, assessments, and test protocols across a diverse Life Science market comprised of Pharmaceuticals, Biotechnology, Cell & Gene Therapy, and Medical Device clients
- Assist in the development and implementation of Quality Management System (QMS) procedures, in harmony with regulatory standards such as ICH Q1, CFR 21 Part 210 and 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10, and 21 CFR Part 11.
- Collaborate with teams to perform investigations, diagnose problems, and troubleshoot validation issues
- Prepare written validation reports with high level of detail and organization
- Communicate with project stakeholders the progress relative to plan
- Manage project deliverables to agreed schedule and scope
- Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
- A passion for a career in the Life Science industry
- Excellent communication and interpersonal skills and ability to interact with all levels of management, clients, and vendors A passion for a career in the Life Science industry
- Excellent communication and interpersonal skills and ability to interact with all levels of management, clients, and vendors
- Bachelor's degree in Bioengineering, Biomedical Engineering, Chemical Engineering, or similar technical degree preferred.
- Project experience in a cGMP manufacturing environment such as pharmaceutical, biotech, or medical device facility
- Project Experience with authoring and executing validation protocols of automation/computerized systems, QC Laboratory equipment, packaging systems, and/or utilities and facilities is desired
- Proficient computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
- Proficient with written and verbal technical communication including generating reports and conducting group presentations.
- Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
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Validation Engineer - Raleigh, United States - Barry-Wehmiller Companies Inc
Description
About Us:Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.
Job Description:
Who You'll Work With
You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class engineer and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.
When you join Design Group as a Validation Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world's leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.
What You'll Do
You'll work individually and in teams to support capital projects, remediation efforts, and change management for our clients. You will assist in the development of new programs, best practices, and program implementation for some of industry's biggest names and many technology-driven companies entering into commercial manufacturing.
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company:
Design Group
