Pharmaceutical Engineering and Validation Expert
3 days ago
Unlock your potential with Takeda Pharmaceutical, a world-class R&D organization dedicated to delivering transformative therapies.
About the RoleWe are seeking an experienced Senior Specialist, Engineering and Validation to join our team. As a key member of our cross-functional group, you will be responsible for ensuring equipment is installed, calibrated, qualified, maintained, and decommissioned in compliance with GxP regulations and internal SOPs.
- Schedule and complete equipment preventative maintenance and calibration activities in Blue Mountain Regulatory Asset Management System
- Active liaison between cross-functional groups, including Quality Assurance, IT, Facilities, Manufacturing, Quality Control, and outsourced vendors to ensure adherence to quality processes and compliance standards
- Own and/or author documentation associated with assigned CQV discipline(s); maintain and improve this documentation as necessary to maintain compliance to government regulations, internal corporate requirements, current industry practices, business needs, and current industry best-practices
Additionally, you will develop and execute studies, commissioning, and validation protocols, assist in deviation resolution, summarize results, and author final reports. Your responsibilities will also include planning and managing protocol execution and coordinating with other departments as necessary.
RequirementsTo succeed in this role, you will need:
- An associate degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science, plus 4+ years of relevant industry experience
- A bachelor's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science, with 2+ years of relevant industry experience
- A 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
Takeda Pharmaceutical is a patient-focused company that inspires and empowers its employees to grow through life-changing work. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
What We OfferWe offer competitive compensation and benefits, including:
- An estimated salary range of $84,000 - $124,000 per year, depending on qualifications and experience
- Medical, dental, vision insurance
- A 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
This role is based in Boston, MA, and requires full-time employment.
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