Engineering Validation Specialist
3 days ago
Takeda is a forward-thinking, world-class R&D organization dedicated to delivering transformative therapies to patients worldwide. We are committed to pushing the boundaries of what is possible in order to bring life-changing treatments to those who need them.
About the RoleWe are seeking a highly skilled Senior Specialist, Engineering and Validation to join our team. As a Senior Specialist, you will be responsible for ensuring that equipment are installed, calibrated, qualified, maintained, and decommissioned in compliance with GxP regulations and internal SOPs. You will also schedule and complete equipment preventative maintenance and calibration activities in Blue Mountain Regulatory Asset Management System.
Key Responsibilities- Ensure equipment are 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.
- Act as an 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.
- 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.
- Responsible for initiation and completion of Change controls, Deviations, CAPA and lab investigations in Trackwise as applicable.
- 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.
As a member of our team, you can expect a competitive salary and benefits package, including:
Estimated Salary Range: $84,000 - $132,000 per year.
Additionally, you may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
We are proud to offer a diverse and inclusive work environment, where everyone has the opportunity to grow and succeed. If you are passionate about making a difference in people's lives and have a strong background in engineering and validation, we encourage you to apply for this exciting opportunity.
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