Company Description
Aumvis PharmaTec, established in 2008, is a premier provider of consulting, engineering, and technical solutions to Pharma, Bio-Pharma, Biotech, Medical Device, and related industries. With offices in the United States and Canada, the company specializes in delivering quality and cost-effective services that help clients ensure compliance with safety and quality standards. Our multidisciplinary team of experts offers custom-designed solutions in areas such as Validation, Process Development, Compliance, and Project Management. Aumvis PharmaTec is dedicated to fostering global health by supporting clients with on-time deliverables that optimize cost and efficiency. We also provide IT and staffing solutions tailored to industry-specific requirements.
Role Description
This is a full-time hybrid role for a Validation Engineer based in Boston, MA. The role involves planning, executing, and documenting validation protocols for equipment, systems, and processes to ensure compliance with regulatory standards. Responsibilities include participating in functional verification tasks, supporting debugging activities, and providing expertise in Good Manufacturing Practice (GMP) compliance. The role also requires collaboration across cross-functional teams to meet project timelines effectively while allowing some flexibility for remote work.
Qualifications
- Experience in Process ans Equipment d
esign - especially- Vial Filler in Isolator.
- Validation and a thorough understanding of Good Manufacturing Practice (GMP) standards
- Proficiency in des
ign review of Vial filler
.
Plan and execute qualification amd APS.
- Strong expertise in identifying and troubleshooting technical issues, with advanced Debugging capabilities
- Ability to collaborate with cross-functional teams and manage multiple projects with attention to detail and deadlines
- Strong problem-solving skills, analytical thinking, and excellent documentation practices
- An advanced degree in Engineering, or a related field is preferred.
- Previous experience within the Pharma, Bio-Pharma, or Medical Device industries is a must
.
