About Us:
BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.
Job Description:
Validation Engineer
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.
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.
What You’ll Do
- Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
- FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry.
- Assist in the development and execution of QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10.
- Work with teams to perform investigations and troubleshoot issues related to validation.
- Prepare written validation reports.
- Experience writing SOP’s, Deviations, and/or CAPA’s.
- Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
What You’ll Bring
- Possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors.
- 2-5 years’ experience with validation of automation, packaging, utilities and/or facilities is desired.
- 2-5 years’ experience in the pharmaceutical, biotechnology, 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.
Education:
- B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.
Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
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