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All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost.

Position Overview:
The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturingoperations.

Company Overview:
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: <a href="https://www.fujifilm.com/us/en/about/region/careers" rel="nofollow" style="color:#000000">https://www.fujifilm.com/us/en/about/region/careers</a>

Job Description:
What You'll Do<ul><li>Develops site technical training programs for new processes and procedures</li><li>Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support</li><li>Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost</li><li>Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes</li><li>As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required</li><li>Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams</li><li>Leads one or more projects spanning multiple departments and cross-functional areas</li><li>Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes</li><li>Leads process sub-teams throughout the phases of TT</li><li>Develops project plans, timelines, and communication forums to ensure a smooth transfer</li><li>Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations</li><li>Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports</li><li>Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)</li><li>As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies</li><li>Generates and executes process training and consults on topics related to manufacturing and process</li><li>Leads and facilitates technical risk assessments for new manufacturing processes</li><li>Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations</li><li>Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management</li><li>Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team</li><li>Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects</li><li>Other duties, as assigned</li></ul>  Minimum Requirements: <ul><li>Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or PhD with 5 years of experience</li><li>Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)</li><li>Experience with facilitating and training others on RCA and risk assessment</li><li>Project Management experience</li></ul>Preferred Requirements:<ul><li>Experience working in a Good Manufacturing Practices (GMP) environment</li><li>Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting</li><li>Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections</li><li>Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings</li></ul>Physical and Work Environment Requirements: <ul><li>Ability to discern audible cues</li></ul> To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information:
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).

Fujifilm

Sr. Scientist 2, Material Science

Biology

Biotech and Pharmaceutical

Campaigns

Capital Expenditure (CAPEX)

Change Control

Chemical Engineering

Chemistry

Clinical Support

Consulting

Continuous Improvement

Corrective Action

Corrective and Preventative Action (CAPA) Systems

Cross-Functional

Document Management

Documentation

Drug Manufacturing

Drug Products

Electronics

GMP (Good Manufacturing Practices)

Healthcare

Identify Issues

Investigational New Drug (IND)

Leadership

Manufacturing

Manufacturing Analysis

Manufacturing Management

Manufacturing/Industrial Processes

Material Science

Materials Analysis

Materials Testing

Medicine

Performance Analysis

Process Analysis

Process Development

Process Validation

Project Development

Project Planning

Project/Program Management

Quality Engineering

Regulations

Reliability Engineering

Resume Search

Risk Analysis

Risk Management

Root Cause Analysis

Site Evaluation

Standard Operating Procedures (SOP)

Technical Analysis

Technical Leadership

Technical Support

Technical Training

Training Program Development

Validation Plan

Validation Testing

[AW]-iCims

General Responsibilities: Under the supervision of the Director of Educational Development, plans and facilitates collaborative computer science learning sessions using a variety of coding languages, robotics, tools, and applications. Required Knowledge, Skills, and Abilities:Ability to work with students of diverse ethnic backgrounds, academic profiles, and skill levels.

Job Title: Computer Science Teacher General Responsibilities: Under the supervision of the Director of Educational Development, plans and facilitates collaborative computer science learning sessions using a variety of coding languages, robotics, tools, and applications. Major Duties: <ul><li>Meets regularly with the Director of Educational Development </li><li>Plans and facilitates learning sessions </li><li>Assists students in the development of computer science and coding skills </li><li>Maintains consistent communication the Director of Educational Development </li><li>Models appropriate academic and social behaviors </li><li>Performs other duties as assigned </li></ul>Required Knowledge, Skills, and Abilities:<ul><li>Ability to work with students of diverse ethnic backgrounds, academic profiles, and skill levels. </li><li>Possess good interpersonal and organizational skills. </li><li>Must demonstrate responsibility, a desire to help others, discretion, and flexibility. </li><li>Knowledge and ability to instruct students in coding languages such as Scratch, Blockly, Swift, and Python. </li><li>Ability to instruct students on how to control a robot (Ozobot, Sphero, drones, etc) using coding languages. </li><li>Ability to collect and analyze data to drive future instruction. </li><li>Ability to work independently applying critical thinking skills and problem solving to various situations. </li><li>Must be able to instruct students of varying skill and experience levels in multiple programs based on interest and ability. </li></ul> Qualifications: Must possess a bachelor's degree, teaching and/or tutoring experience, and have extensive computer science and/or coding experience.

Concorde Education

Computer Science Teacher (Part Time, In-Person) at Concorde Education

Collaborative Learning

Computer Programming

Computer Science

Data Analysis

Data Collection

Diversity

Problem Solving Skills

Python Programming/Scripting Language

Robotics

Training/Teaching

Unmanned Aircraft Systems (UAS)

Hire Recruits

HOUR

General Responsibilities: Under the supervision of the Director of Educational Development, plans and facilitates collaborative computer science learning sessions using a variety of coding languages, robotics, tools, and applications. Ability to work independently applying critical thinking skills and problem solving to various situations.

Job Title: Computer Science Teacher General Responsibilities: Under the supervision of the Director of Educational Development, plans and facilitates collaborative computer science learning sessions using a variety of coding languages, robotics, tools, and applications. Major Duties: <ul><li>Meets regularly with the Director of Educational Development</li><li>Plans and facilitates learning sessions</li><li>Assists students in the development of computer science and coding skills</li><li>Maintains consistent communication the Director of Educational Development</li><li>Models appropriate academic and social behaviors</li><li>Performs other duties as assigned</li></ul>Required Knowledge, Skills, and Abilities: <ul><li>Ability to work with students of diverse ethnic backgrounds, academic profiles, and skill levels. </li><li>Possess good interpersonal and organizational skills. </li><li>Must demonstrate responsibility, a desire to help others, discretion, and flexibility. </li><li>Knowledge and ability to instruct students in coding languages such as Scratch, Blockly, Swift, and Python.</li><li>Ability to instruct students on how to control a robot (Ozobot, Sphero, drones, etc) using coding languages.</li><li>Ability to collect and analyze data to drive future instruction. </li><li>Ability to work independently applying critical thinking skills and problem solving to various situations. </li><li>Must be able to instruct students of varying skill and experience levels in multiple programs based on interest and ability.</li></ul> Qualifications: Must possess a bachelor's degree, teaching and/or tutoring experience, and have extensive computer science and/or coding experience.

Computer Science Teacher (Part Time, In-Person)

Partner GoHire

The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

Position Overview:
The Director, Engineering Science plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) of the organization. This role assesses and designs processes to integrate new equipment, optimize facilities, and enhance operational capabilities. The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. This role is crucial in enhancing site’s process equipment and technology capability offerings and maintaining competitiveness, by making significant contributions to the company’s growth and innovation.

Job Description:
What You'll Do <ul><li>Spearheads technical assessments and process design for equipment and facility integration</li><li>Develops and executes departmental vision and strategy, overseeing the Engineering Science team</li><li>Participates in Request for Proposal (RFP) processes, leading the facility fit assessments, offering technical specifications, feasibility studies, and risk management</li><li>Ensures facilities are well-suited for client programs, focusing on technology integration, scalability, and quality assurance</li><li>Fosters long-term client relationships by ensuring successful project proposals and executions</li><li>Departmental budget adherence</li><li>Manages assessments and feasibility studies for prospective new and expanded process equipment and technology capabilities</li><li>Responsible for technical leadership in the assessment and process design / fits for new process equipment, facility and operational capabilities needed for new client programs, with focus on Drug Substance Biologics production</li><li>Represents Engineering Science as a first point of contact on technical assessments and engineering studies, including technical support for safety assessments</li><li>Actively identifies gaps and suggest/drive implementation of improvements of Drug Substance Biologics production and Drug Product manufacturing capability</li><li>Performs process simulation to optimize throughput and identify potential bottlenecks</li><li>Collaborates with senior internal and external personnel on significant matters often requiring coordination between organizational units</li><li>May act or direct team as technical support lead for Process management of safety incidents investigation</li><li>Manages and develops direct reports</li><li>Administers company policies such as time off, shift work, and inclement weather that directly impact employees</li><li>Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)</li><li>Coaches and guides direct reports to foster professional development</li><li>Participates in the recruitment process and retention strategies to attract and retain talent, as needed</li><li>Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution</li><li>Performs other duties, as assigned</li></ul>Minimum Requirements<ul><li>Bachelor’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 10+ years of experience; OR</li><li>Master’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 8+ years of experience</li><li>6+ years of people management, leadership & team management experience</li></ul>Preferred Requirements <ul><li>Bachelor's/Master’s degree in Biochemical or Chemical Engineering</li><li>Direct experience in Large Scale (20KL Cell Culture Scale) Biologics Drug Substance manufacturing</li></ul>Working & Physical Conditions Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 60 minutes.Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.  To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Science Jobs in Spring Lake, NC

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Science Jobs in Spring Lake, NC

Sr. Scientist 2, Material Science Fujifilm

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