Associate Director, Digital Manufacturing

Position Overview

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 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 Configuration Environment for Batch Activities (CEBA) application
• Drives the technical implementation of RDO and CEBA for all sites, globally
• Defines 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 sites
• Defines and updates the Automation technology transfer process standards for all sites
• Identifies and implements changes to support production and improve quality, as needed
• Trains and shares information of RDO and CEBA 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 RDO and CEBA 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 globally
• 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 YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.