Position Overview:
Ability to stand for prolonged periods of time. No X Yes 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
The Associate Director, Data Integration and Reporting leads and drives the manufacturing data architecture design for the global implementation at FUJIFILM Biotechnologies. This role also leads the system life cycle activities for the global implementation of manufacturing data systems, such as historians, and reporting and integration platforms. This role continues to develop as the organization evolves.
Job Description:
What You’ll Do
- Develops and implements strategies aligned with the company’s goals to optimize processes, improve efficiency, and reduce costs
- Serves as the system owner for the global historian platform
- Drives the technical design and implementation of data integration, globally
- Defines and supports the governance of global manufacturing data platforms
- Ensures effective implementation and adoption of historians, reporting applications, and other data systems across all sites
- Identifies and implements changes to support production and improve quality, as needed
- Trains and shares information of data platforms to the Automation teams and required stakeholders
- Leads global colleagues to effectively implement processes, procedures, and work standards
- Manages relationships with external vendors to properly execute Automation tasks, as needed
- Ensures standards, systems, and processes comply with regulatory requirements (e.g., Good Manufacturing Practices (GMP))
- Directs the technical activities related to reporting applications and data systems to align with the company’s objectives
- Identifies, develops, and revises standard operating procedures (SOPs), as needed
- Identifies opportunities for improvement and collaborates with stakeholders to implement continuous improvement initiatives
- Provides guidance and training to Automation teams and other stakeholders globally, as needed
- Encourages a culture of continuous learning and development while providing real-time feedback and coaching
- Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
- Evaluates team performance, addresses gaps, employee questions and concerns, and partners with HR as needed for resolution, as needed
- Performs other duties, as assigned
Knowledge and Skills
- Ability to adapt communication styles to differing audiences and advise on difficult matters
- Knowledge of biopharmaceutical production within Fill Finish, Utility, Pen’s/devices, and Automation/IT
- Strong strategic thinking skills
- Ability to coach, lead, and train individual contributors
- Ability to effectively present complex information to others
- Effective communication, both written and oral
Basic Requirement
- Bachelor’s degree in Chemical, Electrical, Mechanical Engineering or other relevant field with 11+ years of experience of experience in a regulated industry
- 8+ years of people management/ leadership experience
- Prior experience working in a CGMP facility
- ISA-S88
- ISA-S95
Preferred Requirements
- Master’s degree in a technical field of study relevant to Automation, Instrumentation & Controls, or Business Management with 9+ years of related experience in a regulated industry
- Experience with Lean Six Sigma or other continuous improvement methodologies
- ISA-S18.2
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to stand for prolonged periods of time. No X Yes 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
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