808 Quality Systems Engineer jobs in Worcester,MA

Advanced degree in Chemical Engineering, Biotechnology, or related field
15+ years of experience in biopharmaceutical development and manufacturing (MSAT), process development and technical operations
Strong expertise in technology transfer, scale-up, process validation, and commercial manufacturing support
Deep knowledge of biologics manufacturing and GMP requirements, with a majority of experiences collected from working with antibody based drugs, as e.g. bispecifics and antibody drug conjugates, or other large biologic molecules
Deep understanding of global GMP regulations and lifecycle management requirements (FDA, EMA, ICH)
Experience interacting with regulatory agencies and leading teams through inspections
Proven leadership and cross-functional collaboration skills
Strong analytical and problem‑solving capabilities
Ability to operate effectively in a fast‑paced, growth‑oriented organization
Preferably experience from a global or multi-site manufacturing network
Preferably background with both internal manufacturing and CMO/CDMO oversight

Micron Products

Fitchburg, MA 01420

Insight Global

Framingham, MA 01704

U.S. Navy

Worcester, MA 01604

Yoh

Worcester, MA 01609

Hologic

Marlborough, MA 01752

8 - 12 years of experience as a Solutions or Business Analyst in a regulated manufacturing environment, managing and supporting Quality and/or PLM systems
Hands-on experience with Enterprise Quality Management and Product Lifecycle Management systems (e.g., Oracle Agile PLM/eQMS or similar technologies).
Strong knowledge of core Quality, Regulatory, and PLM functions.
Proficiency in business process analysis, solution design, and system implementation.
Demonstrated success managing multiple deliverables and adhering to project timelines.
Familiarity with General Project Management processes, IT PMO processes and portfolio management.
Demonstrated ability to interact with executive Quality business leadership.
Experience resolving complex business and technical challenges.
Strong analytical mindset with the ability to translate business requirements into functional specifications.
Proven ability to build strong relationships with cross-functional teams and stakeholders.
Excellent presentation and facilitation skills, with the ability to document and communicate processes effectively.
Adaptive communication and collaboration skills to work independently or within a team environment.