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. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, 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 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:
Who You'll Work With
At Design Group, you'll collaborate with experienced leaders, technical specialists, and subject matter experts to solve complex challenges for some of the world's leading companies. You'll join a growing team of more than 1,500 professionals across 45 U.S. offices where you'll be empowered to make an impact, develop your expertise, and grow your career.
What You'll Do
In this role, you'll be responsible for supporting validation and regulatory compliance activities for pharmaceutical, medical device, and other life sciences projects. You'll work closely with validation engineers, project teams, clients, vendors, and technical specialists to develop protocols, execute testing, investigate issues, and document results. This position plays an important role in helping clients demonstrate that equipment, utilities, facilities, and automated systems meet quality and regulatory requirements while giving you hands-on experience in validation engineering and project delivery.
Develop and execute validation and FDA compliance documents and protocols for pharmaceutical equipment and automated systems
Support manufacturing process design, facility development, and project execution activities
Prepare and execute FAT, SAT, IQ, and OQ documentation for equipment and automated systems
Assist with development and execution of quality management system procedures and related compliance documentation
Apply applicable requirements from 21 CFR Parts 211 and 820 and ICH Q1, Q8, Q9, and Q10 to project deliverables
Conduct investigations and support troubleshooting of validation and compliance issues
Prepare clear written validation reports that document testing, results, deviations, and conclusions
Coordinate with clients, vendors, engineers, and project teams to support validation planning and execution
Support installation, start-up, commissioning, and site-based validation activities
Build technical expertise in life sciences validation, quality systems, documentation practices, and regulatory compliance
What You'll Bring
Qualifications
Bachelor of Science in bioengineering, biomedical engineering, chemical engineering, or a related technical degree
Academic, co-op, internship, project, or entry-level experience related to validation, quality, pharmaceutical manufacturing, medical devices, automation, utilities, facilities, or regulated environments
Proficiency using Microsoft Office and ability to prepare clear technical documentation
Ability to organize and execute multiple project responsibilities simultaneously
Ability to travel for project requirements, including installation and start-up activities, client and company meetings, trainings, seminars, forums, and conventions
Preferred Qualifications
Co-op or project experience with validation of automation, packaging equipment, utilities, or facilities
Co-op or project experience in pharmaceutical or medical device environments
Exposure to FAT, SAT, IQ, OQ, quality systems, FDA requirements, or technical report writing
Compensation
The approximate pay range for this position is $75,000-$90,000. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities, as well as geographic location of the position.
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.
Company:
Design Group