Takeda Pharmaceutical Company - Boston, MA
posted 8 days ago
Full-time - Senior
Boston, MA
Chemical Manufacturing
About the position
The Senior Specialist, Engineering and Validation at Takeda is responsible for ensuring that equipment is properly installed, calibrated, qualified, maintained, and decommissioned in compliance with GxP regulations and internal SOPs. This role involves active collaboration with various cross-functional teams to uphold quality processes and compliance standards, as well as managing documentation and validation protocols. The position plays a crucial role in the development and execution of studies and protocols, ensuring adherence to industry best practices and regulatory requirements.
Responsibilities
- Ensure equipment are installed, calibrated, qualified, maintained, and decommissioned in compliance with GxP regulations and per internal SOPs
- Schedule and complete equipment preventative maintenance and calibration activities in Blue Mountain Regulatory Asset Management System
- Act as a liaison between cross functional groups, including Quality Assurance, IT, Facilities, Manufacturing, Quality Control, and outsourced vendors
- Own and/or author documentation associated with assigned CQV discipline(s)
- Develop and execute studies, commissioning, and validation protocols
- Assist in deviation resolution, summarize results, and author final reports
- Plan and manage protocol execution and coordinate with other departments as necessary
- Responsible for business administration of Asset management and environmental monitoring systems
- Initiate and complete Change controls, Deviations, CAPA and lab investigations in Trackwise as applicable
- Occasionally work in a clean room environment and wear special garments and personal protective equipment due to safety requirements
Requirements
- Associate degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 4+ years relevant industry experience
- Bachelor's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 2+ years relevant industry experience
- Working understanding of cGMP, GxP, GAMP and 21CFR part 11 requirements
- Experience with validation lifecycle approach (URS, DQ, IQ, OQ, PQ, etc.)
- Experience with investigations and deviations in a pharmaceutical manufacturing environment.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) plan with company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Sick time
- Paid vacation
