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Job Description
Job Title: Senior Engineer II - Data Integrity and Integration
Location: Lexington, MA
About the Role:
This person will be a key player in the conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and development facilities with a primary focus on Data Integrity and Integration. They will be a primary liaison between Manufacturing, Facility clients, external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning for cGMP production facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory
How you will contribute:
Operational Support:
Implements industry and Takeda best practices for Data Integrity for systems and instrumentation
Leads DI remediation projects and identifies opportunities for improvements
Integrates Systems (LabX, Inmation, PI, etc.) with instrumentation and Equipment in an automated environment
Responsible for developing and implementing integration standards and guidance
Responsible for performing Periodic reviews and User reviews in alignment with procedures
Owns and ensures timely closure of equipment related quality systems System Support
Subject matter expert for Data Integrity and integration
Develops automation related SOPs and standards
Evaluates new technologies for their application within a licensed GMP manufacturing facility
Maintains systems - system & application backups, virus protection, operating system patches, etc.
Programming:
Specifies and documents requirements
Implements requirements following Takeda engineering standard practices
Delivers system design documentation
Programs, configures, and integrates new equipment
Develops, reviews, and approves engineering standard practices through collaboration with partner departments - Plant and Process Engineering, Validation, etc.
Ensure standards are followed and there is cross-site consistency for both in-house and contractor supported changes
Develop commissioning test plans
Provides budgetary and schedule estimates for the requirements of projects
Communicate project requirements to vendors to obtain proposals for hardware and software changes
Provides project team with system requirements
Develops project documentation
Support process and facilities engineers in equipment commissioning and validation
Project Support:
Owns and manages business and quality systems related to projects
Provides and/or ensures generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
Implements changes as specified in requirements documents
Uses project management skills to schedule, track progress, and make adjustments
What you bring to Takeda:
Essential:
Experience: minimum 8-12 years' experience supporting Data Integrity and Integration in an automated GMP environment
Demonstrates understanding of Windows OS, Networking & System Security Fundamentals as well as knowledge implementing integration with Inmation software, PI, LabX, MES and manufacturing instrumentation.
Expert understanding of ALCOA+ and 21 CFR part 11
Knowledgeable in FDA validation requirements preferred, including User Requirement and Design Specs, Business Process Procedures, Design Reviews, Requirements gathering
Experience with SDLC (Waterfall/Agile)
Desired:
Background in Automation including SCADA, PLC, OPC, Continuous/Batch Historians and DCS Based control systems (DeltaV, Rockwell, Siemens, iFix).
Virtualized Server Infrastructure and Networking technologies
ISA-88 (standards and terminology for batch control)
Strong understanding of Data Integrity (per FDA and EMA)
Effective verbal and written communication skills
Able to effectively manage the automation lifecycle of controls components
Ability to effectively document and specify control specifications, both new from the ground up, and changes to existing systems.
Experience with current trends in data integrity, automation and instrumentation to be able to select and implement modern controls architectures
Strong verbal and written communication skills required
Excellent interpersonal skills required
Adherence to domestic and international GMP regulations
Strong organizational and teamwork skills
Ability to multi-task in a dynamic environment with changing priorities
Proficiency with Microsoft products; ability to learn additional software applications, as the need arises - TrackWise and Maximo experience a plus.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
Tuition reimbursement
Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
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EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - MA - Lexington - BIO OPS
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
