Senior or PM level Quality Systems professional responsible for leading projects in remediation, Quality System development, change management, process improvement, and organization master planning. Prior experience with project planning and execution, leading remediation, Quality System Development, and/or leading organizational changes within a Life Science organization is required. This position requires a practical understanding of technical writing, statistics, validation, and relevant Quality Systems regulations for Pharmaceutical, Biotechnology, and/or Medical Devices.
- Responsible for day to day communication, coordination, and organization of onsite project execution activities.
- Provide leadership and mentorship to other professionals.
- Provide high-level master planning and project planning for Quality System Remediation, Validation Planning, and/or other improvement projects.
- Provide customized Quality Systems solutions to clients with challenging and unique needs.
- Provide direction and guidance to clients and other professionals with regards to Quality Systems, Change Management, Investigations, and/or Process Improvement initiatives as defined by DG’s clients.
- Provide review and comments to other professionals with regard to Quality impacting deliverables.
- All Design Group Project Managers will provide leadership skills and experience in Life Science Project Management and will drive growth efforts to expand local and regional clients.
- Minimum 3 years of quality engineering or management experience.
- Must have experience managing and maintaining schedules and coordinating professionals.
- Must have experience developing Project Plans and Execution Strategies.
- Must have experience leading investigations and troubleshooting issues.
- Must have strong computer, written, and verbal communication skills.
- Understanding and experience with Validation activities is preferable.
- Pharmaceutical, Biotech and/or Medical Device project experience is required.
- Strong knowledge of FDA requirements, cGMPs, and standard QMS procedures is required, specifically ISO9001, ISO13485.
- Willing and able to travel as necessary for project requirements to include but not be limited to: project execution and leadership, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
- B.S. in Engineering, Chemistry, Microbiology, or related technical degree.
- Equivalent years of experience in as a Project Manager or Quality Engineer can be substituted for degree.
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.
Barry-Wehmiller Design Group
Why Work Here?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.
Awesome company culture and great opportunities for career advancement!