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. We combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate 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 directly with our clients. 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 will work with a team of industry experts to help 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.
What You’ll Do:
- Responsible for developing and executing 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 SOPs, Deviations, and/or CAPAs.
- Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
What You’ll Bring:
- 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.
- 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. As a Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships.
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 encourage people from all backgrounds to apply to our positions.
Company:
Design Group
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.
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