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FUJIFILM Biotechnologies · 22 hours ago

Engineer 3

Holly Springs, NC

Full-time

Onsite

Senior Level

6+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina, and they are seeking an Engineer/Scientist 3 to provide technology transfer support and technical oversight during manufacturing operations. The role involves conducting experiments, leading troubleshooting efforts, and coordinating process validation runs to ensure efficient manufacturing processes.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Conducts lab and pilot plant experiments

Generates and coordinates execution sampling protocols

Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations

Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems

Leads and supports technology transfer (TT) across multiple unit operation

Coordinates, plans, and executes manufacturing process validation runs

Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations

Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed

Generates and executes process training and consults on topics related to manufacturing and process

Leads technical risk assessments for new manufacturing processes

Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification

Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc

Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab

Interprets and utilizes new knowledge to promptly drive data-based decisions

Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support

Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost

Supports supplier technical

Qualification

Design of ExperienceStatistical Process ControlQuality Systems ExperienceRisk Management ToolsProject ManagementProblem-SolvingTraining SkillsEffective CommunicationRelationship BuildingAdaptability

Required

Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); or

Bachelor's degree in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g., manufacturing)

Master's degree with 3 years of related work experience; or

PhD with no prior experience

Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)

Experience using risk management and RCA tools

Proficient knowledge in Design of Experience (DOE)

Proficient knowledge in Statistical Process Control

Effective communication, both written and oral

Ability to effectively present information to others

Proficient project management skills

Advanced problem-solving skills

Ability to provide feedback to others, including leaders

Ability to develop effective working relationships internally and externally

Ability to adapt communication style to differing audiences and advise others on difficult matters

Preferred

Experience working in a Good Manufacturing Practices (GMP) environment

Prior drug substance and manufacturing experience, including process development, validation, and transfer

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)