Top 410 Validation engineering Jobs in Holly Springs, Nc

Lead eBR Systems Analyst, Operational Technology
United Therapeutics —Research Triangle Park, NC
- Full-time
- 6 years
- Master's degree
- Experience equivalent to degree accepted
- Paid parental leave
- Employee stock purchase plan
Senior Performance/Simulation/Application Engineer
Caterpillar —Clayton, NC
- $112,710 - $169,060 a year
- Full-time
- Engineering
- Pass drug screening
- Analysis skills
- Health savings account
- Paid holidays
Junior Engineers/Scientists/Technicians
ERG —Raleigh, NC
- $60,000 - $75,000 a year
- Online Application
- Bachelor of Science
- 3 years
- Analysis skills
- Profit sharing
- Paid holidays
Quick Apply
Engineer 1, Design Development, R&D
Teleflex —Morrisville, NC
- Microsoft Excel
- Engineering
- English
5d
MTS Digital Engineering
Rambus —Morrisville, NC
- $58,000 - $108,000 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- Electrical Engineering
- Employee stock purchase plan
- Health insurance
Computer System Validation Engineer
Ofni Systems —Raleigh, NC
- Bachelor of Science
- Mid-level
- Communication skills
Senior Analog/Mixed-Signal Hardware Engineer
AFEX Fire Suppression Systems —Raleigh, NC
- $80,000 - $130,000 a year
- Full-time
- 5 years
- Analysis skills
- In-person
- Health savings account
- Health insurance
Quick Apply
Technical Steward
Novartis —Durham, NC
- $126,000 - $234,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Presentation skills
- Health insurance
- 401(k) matching
HIL Test Engineer
SSI People —Raleigh, NC
- $39 - $42 an hour
- Contract
- Mid-level
- In-person
Quick Apply
10d
Manager, Engineering and Quality
Leviton Manufacturing —Fuquay-Varina, NC
- Full-time
- Engineering
- English
- Master's degree
- Paid holidays
- Health insurance
Protection and Control Commissioning Engineer for HVDC, HVDC Protection (US)
Siemens Energy —Raleigh, NC
- Full-time
- Continuous improvement
- Travel
- Senior level
- Paid holidays
- Health insurance
Lead AI and Data Science Engineer II (Secret Clearance Required)
Deloitte —Raleigh, NC
- $134,500 - $265,100 a year
- Full-time
- Computer Science
- 5 years
- Travel
4d
Staff Engineer Systems
Northrop Grumman —Morrisville, NC
- $169,000 - $265,600 a year
- Overtime
- 11+ years
- Java
- Master's degree
- Paid holidays
- Disability insurance
7d
Staff Electromechanical Engineer
Northrop Grumman —Morrisville, NC
- $169,000 - $265,600 a year
- Overtime
- Master's degree
- 8 years
- Bachelor's degree
- Paid holidays
- Disability insurance
3d
Product Development Engineer – Wire Management (On Site)
Voltage LLC —Chapel Hill, NC
- Full-time
- Mid-level
- Office
- Bachelor's degree
- Relocation assistance
- Health insurance
Quick Apply
Electromechanical Engineer or Principal Electromechanical Engineer
Northrop Grumman —Morrisville, NC
- $87,600 - $171,000 a year
- Overtime
- Master's degree
- Bachelor's degree
- Travel
- Paid holidays
- Disability insurance
3d
Principal/Sr. Principal Systems Engineer
Northrop Grumman —Morrisville, NC
- $108,800 - $213,400 a year
- Overtime
- Java
- Master's degree
- AWS
- Paid holidays
- Disability insurance
3d
Sr. Principal Electromechanical Engineer
Northrop Grumman —Morrisville, NC
- $135,800 - $213,400 a year
- Overtime
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
- Paid holidays
- Disability insurance
3d
Build & Test Technician
NIRSense Inc. —Morrisville, NC
- Mid-level
- High school diploma or GED
- Continuous improvement
Quick Apply
Embedded Software Engineer
GridBridge —Raleigh, NC
- Full-time
- Computer Science
- Mid-level
- Linux
- Relocation assistance

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validation engineering jobs near holly springs, nc

Lead eBR Systems Analyst, Operational Technology

United Therapeutics -
Research Triangle Park, NC

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Job Details

Full-time

Benefits

Paid parental leave
Employee stock purchase plan
Disability insurance
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Prescription drug insurance

Qualifications

Data systems development
Database maintenance
Application systems
Document control experience within pharmaceutical industry
GxP
Database systems development
Pharmaceutical regulatory compliance
Software implementation
Configuration management
FDA 21 CFR Part 11
Project management experience in manufacturing
Software administration
Production management software
Computer hardware
Pharmaceutical company experience
Hardware support
Batch records
Managing projects
Pharmaceutical manufacturing facility experience

Full Job Description

California, US residents .

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

The Lead eBR Systems Analyst of Operational Technology will drive the use of GxP electronic forms and batch records to eliminate paper recording of production data. This role will serve as a liaison between OT functional areas deploying and using electronic forms and batch records, providing the highest level of customer satisfaction and partnership, ensuring that OT services are delivered as committed. This person will work closely with the GxP functional areas, vendors, and system owners to understand their current requirements and future roadmap. Additionally they will provide key technical support for various manufacturing and manufacturing support systems such as OpsTrakker, and other GxP Applications and in a regulated, validated environment.

Independently lead project management activities, including defining the scope of the project; creating a project schedule; tracking project progress; communicating with stakeholders; identifying and resolving system issues; leading prioritization; and managing project risks
Manage continuous improvement project portfolio: Evaluate managed GxP and Quality systems, identify opportunities, and make recommendations to Quality and GxP operations' leadership.
Perform and/or coordinate GxP and Quality systems configuration changes for applications in collaboration with functional business units and external consultants
Review system design and scope and execute plans to ensure application meet business requirements and identify gaps
Plan and manage training to end users for modifications to existing processes and/or new functionalities
Lead project and support initiatives, day-to-day support, and off-hour activities on a day-to-day basis
Coach and guide peers/junior team members on Opstrakker and other systems' configuration and business processes
Create documentation and procedures to support the implementation and maintenance of managed GxP and Quality systems
Drive the use of GxP electronic forms and batch records to eliminate paper recording of production data
Collaborate with cross-functional teams, and Technical Teams to identify and resolve issues
Manage GxP and Quality systems' updates
All other duties as assigned

Minimum Requirements

Associate Degree in information technology, chemical engineering or bioengineering or an applicable scientific and/or engineering discipline preferred
10+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on delivering and administering MES, electronic batch record, or other systems with similar functionality with an Associate's Degree or
8+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on delivering and administering MES, electronic batch record, or other systems with similar functionality with a Bachelor's Degree or
6+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on delivering and administering MES, electronic batch record, or other systems with similar functionality with a Master's Degree
Demonstrated experience delivering electronic batch records, electronic forms, or equivalent in a GxP environment
Technical expertise with authoring and maintaining functionality of electronic batch records and electronic forms in a commercial platform
Excellent project management skills
Superior database maintenance / development experience
Computer hardware / software validation and change control experience
Knowledge and experience working in FDA CFR Part 11 compliant environment
Experience working on small, fast paced project teams
Ability to work under pressure and adhere to deadlines
Good verbal and written communications skills
Sound understanding of standard business practices

Preferred Qualifications

Bachelor’s Degree in information technology, chemical engineering or bioengineering or an applicable scientific and/or engineering discipline preferred or
Master’s Degree in information technology, chemical engineering or bioengineering or an applicable scientific and/or engineering discipline preferred
Certified Project Management Professional (PMP)-PMI
Technical expertise with authoring and maintaining electronic batch records and electronic forms in Opstrakker

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

Apply Now

Refine Your Search

validation engineering jobs in holly springs, nc

Lead eBR Systems Analyst, Operational Technology

Senior Performance/Simulation/Application Engineer

Junior Engineers/Scientists/Technicians

Engineer 1, Design Development, R&D

MTS Digital Engineering

Computer System Validation Engineer

Senior Analog/Mixed-Signal Hardware Engineer

Technical Steward

HIL Test Engineer

Manager, Engineering and Quality

Protection and Control Commissioning Engineer for HVDC, HVDC Protection (US)

Lead AI and Data Science Engineer II (Secret Clearance Required)

Staff Engineer Systems

Staff Electromechanical Engineer

Product Development Engineer – Wire Management (On Site)

Electromechanical Engineer or Principal Electromechanical Engineer

Principal/Sr. Principal Systems Engineer

Sr. Principal Electromechanical Engineer

Build & Test Technician

Embedded Software Engineer

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