The Associate Director, Digital Manufacturing leads and drives the Recipe Driven Operation (RDO) design for the global implementation at FUJIFILM Biotechnologies. This role also leads the global technology transfer activities and standards definition as they relate to Automation while defining and supporting the governance for life cycle of RDO and Configuration Environment for Batch Activities (CEBA). This role continues to develop as the organization evolves.
Job DescriptionWhat You’ll Do
Develops and implements strategies aligned with the company’s goals to optimize processes, improve efficiency, and reduce costsServes as the system owner for Configuration Environment for Batch Activities (CEBA) applicationDrives the technical implementation of RDO and CEBA for all sites, globallyDefines and supports the governance of RDO and CEBA cross-site and within the Large-Scale Business Unit (LSBU)Ensures effective implementation and adoption of RDO and CEBA throughout all sitesDefines and updates the Automation technology transfer process standards for all sitesIdentifies and implements changes to support production and improve quality, as neededTrains and shares information of RDO and CEBA to the Automation teams and required stakeholdersLeads global colleagues to effectively implement processes, procedures, and work standardsManages relationships with external vendors to properly execute Automation tasks, as neededEnsures standards, systems, and processes comply with regulatory requirements (e.g., Good Manufacturing Practices (GMP))Directs the technical activities related to RDO and CEBA to align with the company’s objectivesIdentifies, develops, and revises standard operating procedures (SOPs), as neededIdentifies opportunities for improvement and collaborates with stakeholders to implement continuous improvement initiativesProvides guidance and training to Automation teams globallyEncourages a culture of continuous learning and development while providing real-time feedback and coachingCompletes 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 neededPerforms other duties, as assignedKnowledge and Skills
Ability to adapt communication styles to differing audiences and advise on difficult mattersKnowledge of biopharmaceutical production within Fill Finish, Utility, Pen’s/devices, and Automation/ITStrong strategic thinking skillsAbility to coach, lead, and train individual contributorsAbility to effectively present complex information to othersEffective communication, both written and oralBasic Requirement
Bachelor’s degree in Chemical, Electrical, Mechanical Engineering or other relevant field with 11+ years of experience of experience in a regulated industry8+ years of people management/ leadership experiencePrior experience working in a CGMP facilityISA-S88ISA-S95Preferred 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 industryExperience with Lean Six Sigma or other continuous improvement methodologiesISA-S18.2WORKING 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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