Top 8 Senior validation engineer Jobs in Sanford Nc

Sr. Scientist 2, Material Science
FUJIFILM —Holly Springs, NC
- Call employer
- Engineering
- 3 years
- Doctor of Philosophy
Sr Scientist-Engineer 1, Process Validation
FUJIFILM —Holly Springs, NC
- Call employer
- 6 years
- Engineering
- Senior level
Senior Electrical Engineer
Amgen —Holly Springs, NC
- $115,494.60 - $156,257.40 a year
- On call
- Doctoral degree
- Master's degree
- High school diploma or GED
Senior OSS Infrastructure Engineer - Linux, Docker, Kubernetes
Fujifilm —Holly Springs, NC
- Azure
- System design
- Windows
- Wellness program
- Health savings account
Senior DevOps Engineer – Data Engineering
innoVet Health, LLC —United States
- From $140,000 a year
- Full-time
- Remote
- HIPAA
- SQL
- AWS
- Health insurance
- Dental insurance
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Sr Scientist-Engineer 1, Process Validation
FUJIFILM —Holly Springs, NC
As technical SME, leads or supports generation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy,…
Sr. Scientist 2, Material Science
FUJIFILM —Holly Springs, NC
Acts as a scientific liaison between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier…

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Sr. Scientist 2, Material Science

FUJIFILM -
Holly Springs, NC

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Job Details

Qualifications

Full Job Description

Position Overview

The Sr Engineer or Scientist of Material Science 1 manages the design and development of new single-use consumables in conjunction with our manufacturing teams. This role manages the leachable and extractables program, including organizing testing and creating a data library based on products evaluated. This role also supports manufacturing investigations involving items such as: raw material variability and concerns, consumable issues, particle sources, and provides impact assessments in collaboration with other Process Science subject matter experts (SMEs). Additionally, this role writes investigation reports and leachable and extractable reports. The Sr Engineer or Scientist is the SME for customer and regulatory audits and
articulates the Fujifilm Biotechnologies procedures, practices and rationale.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

Provides oversight and supports the team with the introduction of new raw materials, and associated document requirements
Ensures regulatory compliance, assesses vendor change notifications, and provides strategic input on raw materials related matters
Oversees and supports change requests for introduction, modification, and discontinuation of raw materials
Acts as a scientific liaison between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
Develops and implements training for manufacturing staff on process improvement initiatives, as needed
Leads or coordinates troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
Supports process sub-teams throughout the phases of technology transfer (TT)
Serves as SME to support TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
Supports generation of sampling plans for process validation reports (PVRs) and investigations
As technical SME, leads and supports generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures or policies
Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and 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

Minimum 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 working in Good Manufacturing Practices
(GMP) environment

Preferred Requirements:

Prior drug substance or manufacturing experience,including expertise in process validation, transfer and
commercialization, and manufacturing support and troubleshooting
Experience supporting or writing portions of regulatory filings and supporting regulatory audits
Direct experience with new product launches and validation of
process
Experience managing global or multi-site validation programs

Physical and Work Environment Requirements:

Ability to discern audible cues

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 ([email protected]).

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senior validation engineer jobs in sanford nc

Sr. Scientist 2, Material Science

Sr Scientist-Engineer 1, Process Validation

Senior Electrical Engineer

Senior OSS Infrastructure Engineer - Linux, Docker, Kubernetes

Senior DevOps Engineer – Data Engineering

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