Senior Process Validation Engineer/Scientist

4 weeks ago

raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The Sr Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works closely with cross-functional teams to ensure that processes are consistently producing high-quality products in a safe and efficient manner.

What You’ll Do

  • Provides oversight and supports the team with process validation requirements
  • Ensures regulatory compliance, assesses change notifications, and provides strategic input on process validation related matters
  • Develops process validation strategy and leads execution of all aspects of process validation including process performance qualification runs, continued process verification, and other validation studies
  • Works with Validation (CQV) to support Performance Qualification execution and assessments for at-scale process validation requirements (e.g., worst-case soiling for cleaning validation, microbial hold, and mixing validation)
  • Supports process sub-teams throughout the phases of technology transfer (TT)
  • Leads generation of sampling plans for process validation reports (PVRs) and investigations
  • Writes and reviews documentation for internal and external use such as validation campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments, etc.
  • Develops and implements training for manufacturing staff on process validation requirements
  • Leads or supports troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations, as needed
  • Serves as subject matter expert (SME) to support TT stage gate reviews on incoming processes for manufacturing readiness (e.g., acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for proposed changes)
  • As technical SME, leads or supports generation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, extractable and leachable assessment, and other site procedures/policies
  • Leads continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
  • Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements, and associated requirements
  • Other duties, as assigned


Knowledge and Skills

  • Network with key contacts outside own area of expertise. Adapts style and uses persuasion in delivering messages that relate to the wider firm business.
  • Frequently advises others on complex matters. May be accountable through team for delivery of tactical business targets.
  • Organizational impact and influence
  • Ability to successfully navigate high stakes, crucial conversations
  • Ability to distill complex concepts into meaningful information for all audiences
  • Ability to generate mechanistic and theoretical hypotheses
  • Ability to effectively present information to othersStrategic thinking and self-directed
  • Proficient in use of Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
  • Strong knowledge of process validation principles across all 3 stages (Process Design, Process Qualification, and Continued Process Verification)
  • Excellent communication and teamwork skills
  • Ability to remain current on regulatory and quality requirements for manufacturing


Basic Requirements

  • Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience; or
  • Master's degree in in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience; or
  • PhD with 3 years of relevant experience
  • Experience using Risk Management and root cause analysis tools
  • Experience working in Good Manufacturing Practices (GMP) environment


Preferred Requirements

  • Prior drug substance or manufacturing experience, including expertise in new product launch, process validation and commercialization
  • Experience with regulatory audits and inspections and regulatory requirements such as FDA 21 CFR part 11
  • Experience supporting or writing portions of regulatory filings
  • Experience managing global or multi-site validation programs


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.

  • Senior Process Validation Engineer/Scientist

    1 month ago

    raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...

  • Senior Process Validation Engineer/Scientist

    1 month ago

    Raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...

  • Senior Validation Specialist

    4 weeks ago

    Raleigh, North Carolina, United States Validation & Engineering Group Inc. Full time

    Job Title: Senior Validation SpecialistAbout Us:Validation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries.Job Summary:We are seeking a talented and dedicated Senior Validation Specialist to join our team. The ideal candidate will have expertise...

  • Senior Process Validation Engineer/Scientist

    2 weeks ago

    Raleigh, NC, United States FUJIFILM Diosynth Biotechnologies Full time

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...

  • Validation Specialist

    1 month ago

    Raleigh, North Carolina, United States Validation & Engineering Group Full time

    Job OverviewValidation & Engineering Group, Inc. is a leading services provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. We are seeking a talented individual to join our team as a Validation Specialist.Key ResponsibilitiesDevelop and implement validation protocols for process equipment and...

  • Validation Specialist

    3 weeks ago

    Raleigh, United States Validation & Engineering Group Inc. Full time

    Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking for talented, dedicated individuals who...

  • Validation Specialist

    3 weeks ago

    Raleigh, United States Validation & Engineering Group Inc. Full time

    Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking for talented, dedicated individuals who...

  • Senior Validation Engineer

    3 months ago

    Raleigh, United States Disability Solutions Full time

    Senior Validation Engineer at Precision Medicine Group (View all jobs) Raleigh, North Carolina, United States Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we...

  • Senior Chemical Process Engineer

    1 month ago

    Raleigh, North Carolina, United States Mallinckrodt Pharmaceuticals Full time

    Job SummaryThe Senior Chemical Process Engineer will play a key role in the APAP Operations Team, applying technical expertise to manage day-to-day production, optimize plant operation, and resolve operational issues. This position requires a strong understanding of chemical and chemical engineering principles to solve production, quality, and throughput...

  • Senior Data Scientist I

    1 month ago

    Raleigh, North Carolina, United States RELX Full time

    About the RoleWe are seeking a highly skilled Senior Data Scientist to join our team at LexisNexis Legal & Professional. As a Senior Data Scientist, you will be responsible for defining projects and their execution, working closely with other data scientists and engineers to design, develop, and deploy cutting-edge AI solutions.You will lead AI and machine...

  • Validation Engineer

    1 month ago

    Raleigh, United States Piper Companies Full time

    Piper Companies is actively seeking a Validation Engineer to join a global pharmaceutical organization that specializes in diabetes care, among other products and services. Having one of the broadest diabetes products portfolio in the healthcare industry. The Validation Engineer will drive process improvement projects alongside a team of Engineers, located...

  • Senior Validation Specialist

    4 weeks ago

    Raleigh, North Carolina, United States Piper Companies Full time

    Piper Companies is seeking a skilled Validation Engineer to drive process improvement projects in a global pharmaceutical organization specializing in diabetes care. Located on the outskirts of Raleigh, NC, the Validation Engineer will collaborate with a team of Engineers to enhance the company's diabetes products portfolio.Key Responsibilities: Develop and...

  • Senior Bioinformatics Engineer and Data Scientist

    1 week ago

    raleigh, United States Pathfinder Oncology Full time

    About Pathfinder OncologyPathfinder Oncology, Inc (PFO) pathfinderoncology.com, based in Research Triangle Park, North Carolina, is a newly established, agile oncology company dedicated to providing personalized navigation expertise and pioneering therapies for patients with cancer. A key part of our thesis is the necessity of anti-tumor immunity for...

  • Senior Bioinformatics Engineer and Data Scientist

    2 weeks ago

    raleigh, United States Pathfinder Oncology Full time

    About Pathfinder OncologyPathfinder Oncology, Inc (PFO) pathfinderoncology.com, based in Research Triangle Park, North Carolina, is a newly established, agile oncology company dedicated to providing personalized navigation expertise and pioneering therapies for patients with cancer. A key part of our thesis is the necessity of anti-tumor immunity for...

  • Senior Bioinformatics Engineer and Data Scientist

    2 weeks ago

    Raleigh, United States Pathfinder Oncology Full time

    About Pathfinder OncologyPathfinder Oncology, Inc (PFO) pathfinderoncology.com, based in Research Triangle Park, North Carolina, is a newly established, agile oncology company dedicated to providing personalized navigation expertise and pioneering therapies for patients with cancer. A key part of our thesis is the necessity of anti-tumor immunity for...

  • Senior Process Design Engineer

    1 month ago

    Raleigh, North Carolina, United States Integrated Project Services Full time

    Job DescriptionAt Integrated Project Services, you will apply your knowledge, skills, and passion to make a difference in the lives of people by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a dedicated Senior Process Design Engineer to join our talented team at our...

  • Senior Chemical Process Engineer

    4 weeks ago

    Raleigh, North Carolina, United States Mallinckrodt Full time

    Job Title: Sr. Chemical Process Engineer Requisition: JR Sr. Chemical Process Engineer (Open) Location: Raleigh, NC Job Description Summary: The Sr. Production Engineer will function as a part of the APAP Operations Team. The Sr. Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational...

  • Senior Chemical Process Engineer

    1 month ago

    Raleigh, North Carolina, United States Mallinckrodt Pharmaceuticals Full time

    Job SummaryMallinckrodt Pharmaceuticals is seeking a highly skilled Senior Chemical Process Engineer to join our team. As a key member of our operations team, you will be responsible for managing day-to-day production, optimizing plant operation, and resolving operational issues. Your technical expertise and leadership skills will enable you to provide...

  • Senior Data Scientist III

    4 weeks ago

    Raleigh, North Carolina, United States RELX Full time

    Job SummaryWe are seeking a highly skilled Senior Data Scientist III to join our team at RELX. As a key member of our data science team, you will be responsible for designing, developing, and deploying AI solutions that drive business growth and improve customer experiences.Key ResponsibilitiesDesign and develop advanced AI and machine learning models to...

  • Machine Learning Engineer/Data Scientist

    3 days ago

    Raleigh, United States PDSSOFT INC. Full time

    Data ScientistLocation: RTP,NCDuration: Long TermJob Description:5+ years of Data Science with proficiency in Python and experience with machine learning frameworks and libraries (e.g., scikit-learn, TensorFlow, PyTorch).Technical Experience: 2+ years of experience in Technical Python, AWS, and data analysis tools such as SQL and Pandas.We are seeking a...