Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Staff Engineer, Cell Therapy GMP Manufacturing Systems in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Staff Engineer working on the Cell Therapy GMP Manufacturing team, you will be empowered to develop and implement Cell Therapy GMP Manufacturing IT systems and work to integrate these systems into Takeda s existing structure, and a typical day will include:
The primary focus of the Manufacturing Systems Engineer will be to assist in developing, implementing and maintaining the digital manufacturing systems for Takeda s new GMP cell therapy manufacturing facility. This position will directly contribute to the successful delivery of products in support of clinical trials, serving as the primary liaison between Manufacturing and IS/IT groups during facility build-out and operations.
- Support the selection, installation, configuration and maintenance of the sites manufacturing computer and automation systems. This includes building automation and monitoring systems, data historians, MES, LIMS, ERP and EBR platforms.
- Collaborate with IT organization to integrate systems into Takeda global network and IT systems in accordance with global and local policies
- Demonstrate expertise in hardware and software design principles, as well as serve as a primary integrator for key manufacturing technologies and applications
- Assists in the writing and review of functional requirements and design documents, test protocols and reports, and operational SOP s for computer and automation systems
- Thoroughly document all aspects of tests, including requirements, design, operation and qualification in compliance with GMP procedures
- Participate in cross-functional team integrating manufacturing and clinical data to improve processes and patient outcomes
- Collaborate with process and analytical development teams in selecting equipment and software and integrating them into the digital platforms
- Support manufacturing operations with troubleshooting and resolution of problems related to computer and automation systems
- Provide technical expertise and guidance and conduct training sessions for facility staff members
- Update and maintain manufacturing execution systems in support of new product campaigns and additional process and analytical equipment
- Participate in validation of systems in collaboration with IT, QA and third-party SME s
- Support regulatory filings and audits as required.
- Assist in the execution of process change controls and CAPA s in accordance with company procedures and policies
- Will require occasional work in a clean room manufacturing environment, including gowning.
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
- Bachelors degree in Engineering, Computer Science or related technical field; 8+ years of relevant work experience
- Masters degree in Engineering, Computer Science or related technical field; 6+ years of relevant work experience
- Working understanding of cGMP manufacturing, operations and practices; experience in other highly regulated industries may be considered
- Experience with computer systems validation practices (GAMP)
- Understanding of cGMP regulatory compliance in the biotech manufacturing environment and electronic records storage (21 CFR Part 11)
- Experience with installing, configuring, validating and maintaining MES, LIMS and EBR systems
- Management of contractors and consultants as needed during system implementation
- Experience with facility utility and monitoring systems preferred
- IT savvy, experience with IT systems management and associated processes, networking experience a plus
Knowledge and Skills:
- Teamwork Ability to work well in a fast-paced multi-disciplinary environment
- Communication - Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
- Organization Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
- Motivated Self-motivated and willing to accept temporary responsibilities outside of initial job description
- May require occasional weekend work in support of manufacturing operations
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.