Senior Process Engineering Specialist

2 weeks ago

Durham, North Carolina, United States FUJIFILM Holdings America Corporation Full time
Overview

The Senior Process Engineering Specialist serves as a key representative of the technical operations division at FUJIFILM Holdings America Corporation, engaging with clients, regulatory bodies, and internal management. This role is pivotal in overseeing the integration of new client processes and ensuring that project goals are met effectively. The individual will also play a significant role in the technology transfer across various stages of project life cycles, from clinical materials to commercial production. A robust understanding of processes is essential for executing risk assessments and conducting process and cleaning qualification and validation activities.

Key Responsibilities:

Primary Duties

  • Facilitates the technical transfer of client projects into manufacturing environments as necessary.
  • Compiles and presents data summaries and reports.
  • Collaborates with supervisors to communicate results and interpretations of experiments, project deliverables, and process readiness.
  • Provides technical expertise to support capital projects.
  • Conducts assessments for new project site-fit as required.
  • Assists in the development of standard operating procedures (SOPs) and engineering documentation.
  • Stays informed about relevant industry literature.

Required Skills:

  • Proficient in utilizing computer systems and software for data acquisition and analysis.
  • Capable of performing basic data analysis using standard software tools.
  • Competent in fundamental mathematical and software skills, including Excel for data visualization and MS Word for documentation.
  • Understands Good Manufacturing Practices (GMPs), safety protocols, and standard operating procedures.
  • Possesses knowledge of basic production processes and troubleshooting techniques.

Supervision:

  • Operates under close to moderate supervision, with limited scope for independent decision-making.

Problem-Solving Abilities:

  • Exhibits a practical understanding of engineering principles and applies this knowledge to support product development and technical transfers.
  • Develops solutions for a range of moderate complexity problems.
  • Consults with senior colleagues on straightforward process engineering projects to gain practical experience.

Communication Skills:

  • Maintains comprehensive records of ongoing projects in compliance with documentation standards.
  • Prepares data summaries for technical reports, including memos and development reports.
  • Drafts SOPs and other cGMP documentation.
  • Engages in collaboration and communication within and across teams as necessary.
  • May present updates at departmental meetings to inform management and team members about project activities.

Leadership Qualities:

  • Takes accountability for personal actions and their outcomes.
  • Demonstrates a willingness to share responsibilities with team members to enhance team progress.
  • Practices active listening and is open to feedback from peers.

Qualifications:

  • Bachelor's degree or equivalent experience with a minimum of 4 years in the field, or a Master's degree.
  • Strong knowledge of advanced techniques in biology, chemistry, or biochemistry.
  • Demonstrated ability to independently operate complex instrumentation and utilize software for data analysis.
  • General proficiency in Excel, Word, and PowerPoint.
  • Understanding of analytical or process experimental design.
  • Demonstrates a solid grasp of instruments, computer technology, and data analysis necessary for successful project execution.

FUJIFILM Holdings America Corporation is committed to equal opportunity employment. All qualified candidates will be considered for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

  • Process Engineering Specialist

    2 weeks ago

    Durham, North Carolina, United States CARsgen Therapeutics Full time

    Join Our Innovative Team at CARsgen TherapeuticsWe are excited to announce an opening for a Process Engineering Specialist at CARsgen Therapeutics. This position presents a remarkable opportunity to enhance your career in Engineering while playing a vital role in the manufacturing of advanced CAR-T therapies. As a Process Engineering Specialist, you will...

  • Senior Process Engineer

    2 weeks ago

    Durham, North Carolina, United States CARsgen Therapeutics Full time

    Position Overview:The Senior Process Engineer at CARsgen Therapeutics' facility plays a pivotal role in the technical aspects of CAR-T therapy production. This position offers an excellent opportunity for professional development within the Maintenance and Engineering sectors, focusing on cutting-edge manufacturing processes. The individual will be...

  • Process Engineering Specialist

    2 weeks ago

    Durham, North Carolina, United States CARsgen Therapeutics Full time

    Join Our Innovative Team at CARsgen TherapeuticsWe are excited to announce an opening for a Process Engineering Specialist at CARsgen Therapeutics. This position presents a remarkable opportunity to enhance your professional journey in Engineering and Maintenance while playing a vital role in the development of advanced CAR-T therapy manufacturing. In this...

  • Senior Process Engineer III

    2 days ago

    Durham, North Carolina, United States Compunnel Inc. Full time

    Job Summary:We are seeking a highly skilled Senior Process Engineer III to lead and innovate in our dynamic team. As a key member of our manufacturing team, you will be responsible for providing hands-on support for the installation, start-up, and debugging of cutting-edge cable manufacturing equipment.Key Responsibilities:Provide technical expertise to...

  • Manufacturing Process Specialist II

    2 weeks ago

    Durham, North Carolina, United States Novo Nordisk AS Full time

    Role Overview:As a Process Engineer II, you will play a crucial role in enhancing and innovating systems and machinery essential for our core operations. Your efforts will ensure compliance with customer expectations, business objectives, and regulatory standards.Key Responsibilities:- Focus on People: Collaborate with cross-functional teams to foster a...

  • Senior Process Engineering Leader

    2 weeks ago

    Durham, North Carolina, United States Elo Life Systems Full time

    POSITION OVERVIEWReporting directly to the Senior Vice President of Global Manufacturing, Operations, and Regulatory Affairs, the Senior Process Engineering Leader will play a pivotal role within the Manufacturing division. This position is tasked with the development and oversight of Elos pilot initiatives, collaborating closely with Research and...

  • Lead Process Engineering Specialist

    2 weeks ago

    Durham, North Carolina, United States FUJIFILM Holdings America Corporation Full time

    OverviewThe Lead Process Engineering Specialist serves as a key representative of the technical operations division, engaging with clients, regulatory bodies, and internal management. This role is positioned within the Process Sciences sector of FUJIFILM Holdings America Corporation.Key Responsibilities:Oversee technical transfer and process validation for...

  • Advanced Process Sciences Engineer

    2 weeks ago

    Durham, North Carolina, United States FUJIFILM Corporation Full time

    Position OverviewThe Lead Process Engineering Specialist serves as a key representative of the technical operations division for FUJIFILM Corporation, engaging with clients, regulatory bodies, and internal management. This role is situated within the Process Sciences department and is considered a mid-level position.This position will report directly to the...

  • Manufacturing Process Specialist

    2 weeks ago

    Durham, North Carolina, United States ROYAL METAL POWDERS, LLC Full time

    Job OverviewThe Manufacturing Process Specialist will spearhead process enhancement and support within the metal powder production sector. This role involves collaborating with a diverse team of engineers, including process, project, and metallurgical engineers, to drive productivity improvements through effective management of process advancements utilizing...

  • Manufacturing Process Specialist

    2 weeks ago

    Durham, North Carolina, United States ROYAL METAL POWDERS, LLC Full time

    Job OverviewThe Manufacturing Process Specialist will spearhead process enhancement and support within the realm of metal powder production. This role involves collaboration with a diverse team of engineers, including process, project, and metallurgical engineers. The primary focus will be on boosting productivity through the implementation of process...

  • Manufacturing Process Specialist

    2 weeks ago

    Durham, North Carolina, United States Cormetech Inc Full time

    Job OverviewPosition Summary:The Manufacturing Process Specialist plays a crucial role in ensuring that the production and activation sectors achieve their objectives for efficiency, product quality, and equipment reliability. This role is pivotal in overseeing the manufacturing workflow, guaranteeing that high-quality products are produced safely and...

  • Manufacturing Process Specialist

    2 weeks ago

    Durham, North Carolina, United States ROYAL METAL POWDERS, LLC Full time

    Job OverviewThe Manufacturing Process Specialist will spearhead the enhancement and support of processes within the metal powder production sector. This role involves collaboration with a diverse team of engineers, including process, project, and metallurgical engineers, to drive productivity improvements through the application of Lean Manufacturing...

  • Senior Applications Engineering Specialist

    2 weeks ago

    Durham, North Carolina, United States Synopsys Full time

    Applications Engineering OverviewAt Synopsys, we are at the forefront of technological advancements that transform our daily lives. From autonomous vehicles to cutting-edge AI, our innovations are shaping the future. We are dedicated to delivering the most sophisticated technologies for chip design and software security, driving the Era of Smart...

  • Construction Project Specialist

    2 weeks ago

    Durham, North Carolina, United States U.S. Engineering Full time

    U.S. Engineering has established itself as a frontrunner in the industry since 1893 through relentless innovation and adaptability. We embrace the rapid changes in the construction sector, fostering a vibrant workplace where even our newest team members can drive transformation and make a significant impact. We recognize that our greatest asset is our...

  • Senior Accounting Specialist

    2 weeks ago

    Durham, North Carolina, United States Innovative Talent Solutions Full time

    Job OverviewSenior Accounting Specialist – Direct Hire OpportunityDue to an upcoming retirement, an exciting opportunity has arisen for a Senior Accounting Specialist at a prominent firm in the Triangle area.What We Offer:As a Senior Accounting Specialist, you will enjoy a competitive salary, attractive bonus structure, comprehensive medical/dental/vision...

  • Senior Engineer

    2 weeks ago

    Durham, North Carolina, United States City of Durham Full time

    Position Overview:Join the City of Durham as a Senior Engineer in the Stormwater Management Review Specialist role, where you will play a crucial part in ensuring compliance with stormwater regulations through meticulous review of development plans.Salary: $76,399 - $118,415 AnnuallyLocation: Durham, NCJob Type: Full-time with benefitsWork Environment:...

  • Manufacturing Process Specialist

    2 weeks ago

    Durham, North Carolina, United States Corning Incorporated Full time

    Manufacturing Process Specialist - PlasticsCompany: Corning IncorporatedCorning is a key player in advancing the industries we influence and the world we inhabit.We create transformative technologies through materials science. Our scientific and manufacturing capabilities, relentless curiosity, and dedication to meaningful innovation position us at the...

  • Manufacturing Process Specialist

    2 weeks ago

    Durham, North Carolina, United States Cormetech Inc Full time

    Job OverviewPosition Summary:The Manufacturing Process Specialist plays a crucial role in ensuring that the oven and activation sectors achieve optimal performance in terms of throughput, yield, and equipment reliability. This role is vital for maintaining the production of high-quality products in a safe and efficient manner. The individual will oversee the...

  • Wafer Processing Engineer

    3 days ago

    Durham, North Carolina, United States Micross Components Full time

    Job OverviewMicross Components is seeking a highly skilled and motivated individual to join our Process Engineering team as a Wafer Processing Engineer. This role will involve extensive hands-on experience in wafer processing, including wet processing, thin film depositions, dry etching, and electroplating.Key ResponsibilitiesPerform wafer processing tasks...

  • Senior Reliability Engineer I

    2 weeks ago

    Durham, North Carolina, United States Biogen Full time

    About This Position The Senior Reliability Engineer I plays a crucial role in enhancing the reliability and performance of essential assets within the organization. This position involves the application of advanced Reliability Engineering principles to ensure optimal design specifications and operational efficiency. Key Responsibilities: Develop and...