Barry Wehmiller Company-posted 8 months ago
Full-time • Mid Level
Boston, MA
Machinery Manufacturing

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. 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.

  • Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
  • Travel to top clients across the country to assist in the design of manufacturing processes.
  • Help manage projects and develop facilities.
  • Conduct 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.
  • Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
  • Good communication and interpersonal skills.
  • Flexibility with tasks and the ability to interact with all levels of management, clients, and vendors.
  • Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities.
  • Minimum of 3 years project experience in the pharmaceutical, biotechnology, or medical device environments is a plus.
  • Experience in a gown-room environment is a plus.
  • 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.
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