- The role supports the validation of plant automation and process control systems, along with QC laboratory and Desktop based business and analytical systems.
- The role will provide leadership in scheduling, planning and execution of validation projects for site based computer systems.
- The role will develop, complete, log and archive computer systems validation documentation
- Defining validation strategies and oversight through the implementation of validations plans for site based computer systems.
- Sound industry knowledge, project proficiency, and autonomy expected. Considered a validation Subject Matter Expert (SME) in the areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
- Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP 5 requirements.
- Lead risk assessments to identify critical SDLC activities and deliverables during the implementation and validation of various computer systems.
- Plan computer validation projects and track execution of validation activities versus project timeline. Manage and plan the work of the internal and contract resources.
- Perform change control assessments and write/review validation plans, qualification protocols and summary reports. Manage the execution of qualification protocols and review test results.
- Mentor junior staff in their job performance and project related activities.
- Supporting development of best demonstrated validation practices within the validation department, based on current industry practices and regulatory guidelines.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Minimum of a BS in Sciences/Engineering (other degrees accepted provided the individual has relevant experience
- Minimum of 5-8 years relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry with 2-3 years experience in leading resources and projects
- Working knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, EU's Annex 11 guidelines and other international regulatory requirements.
- Have previous validation experience in Rockwell Automation, FTView SE, ControlLogix, FTBatch, SQL Databases and OSI Pi as well as lab equipment and software such as QC LIMS and Empower, building automation, and IT infrastructure.
- Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in related disciplines.
- Lead and manage various validation activities and author/review related documents including validation plans, risk assessments, 21 CFR compliance assessments, qualification protocols, and summary reports.
- Lead qualification protocol execution, and manage protocol deviations investigation and corrective action activities
- Participate in user/system requirements gathering, design qualification, and CAPA investigations.
- Collaborate closely with supplier quality and system owners in defining the role of software suppliers. Assist in evaluation and oversight of supplier activities and documentation related to system qualification.
- Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, Project and other desktop computing software.
- Able to establish and manage multiple cross-functional teams simultaneously.
- Project management experience preferred
- In general, the position requires a combination of sedentary work and walking around the cGMP manufacturing facility.
- May occasionally work in a clean room environment and wear special garments and personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
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