Top 92 Senior validation engineer Jobs in Holly Springs, Nc

Senior Validation Engineer
PSC Biotech —Durham, NC
- Full-time
- Computer Science
- Engineering
- Mentoring
- Paid holidays
- Disability insurance
14d
Senior Data Engineer
Ken Systems —Raleigh, NC
- Contract
- Remote
- Computer science
- Computer Science
- SQL
Senior Manufacturing Systems Engineer
Amgen —Holly Springs, NC
- $142,955 - $165,280 a year
- Online Application
- Hybrid work
- Mid-level
- SQL
- 4 years
- Disability insurance
- Health insurance
3d
Senior ETL Test Engineer
Optum —Raleigh, NC
- $91,700 - $163,700 a year
- Full-time
- Remote
- Computer Science
- Pass drug screening
- System design
Senior Data Engineer
First Citizens Bank —Raleigh, NC
- Full-time
- Remote
- Azure
- High school diploma or GED
- SQL
Senior Principal Mechanical Engineer
Targan Inc —Raleigh, NC
- Full-time
- ERP systems
- 11+ years
- Master's degree
Quick Apply
Senior Vision Software Engineer (R&D)
Targan Inc —Raleigh, NC
- Full-time
- Computer science
- Azure
- Computer Science
Quick Apply
Sr. Hardware Design Engineer
Actalent —Morrisville, NC
- $130,000 - $170,000 a year
- Full-time
- Schematics
- 5 years
- Laboratory experience
- Profit sharing
- Health insurance
Quick Apply
7d
Sr. Software Dev Engineer Test
MetLife —Cary, NC
- $133,400 - $172,200 a year
- Email
- Azure
- Computer Science
- Research
- Paid holidays
- Disability insurance
7d
Sr Engineer 1, Process Validation
FUJIFILM —Holly Springs, NC
- Call employer
- 6 years
- Engineering
- Senior level
Senior Validation Engineer
CAI —Raleigh, NC
- $87,100 - $120,200 a year
- Full-time
- Bachelor of Science
- 3 years
- Travel
- Opportunities for advancement
Quick Apply
Senior Principal Engineer, Inspection
Genentech —Holly Springs, NC
- $114,400 - $212,400 a year
- Online Application
- 11+ years
- Office
- Bachelor's degree
Senior Security Engineer
Cisco Systems —Research Triangle Park, NC
- $137,000 - $277,600 a year
- Full-time
- Hybrid work
- Office
- Master's degree
- Bachelor's degree
- Paid parental leave
- Paid holidays
Data/Senior Data & Analytics Engineer (PI, MQTT and UNS)
Genentech —Holly Springs, NC
- $78,900 - $176,800 a year
- Online Application
- Computer Science
- Construction site
- 5 years
Senior Manufacturing Systems Engineer – DeltaV
Amgen —Holly Springs, NC
- $136,906.95 - $185,227.05 a year
- On call
- Doctoral degree
- Computer Science
- Master's degree
Senior Project Engineer Clean Utilities
Genentech —Holly Springs, NC
- $90,600 - $168,200 a year
- Online Application
- Up to 50% travel
- Travel
- In-person
Senior Process Engineer - Solution Prep, Upstream, and Downstream
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 System Software Engineer – Data Center Compute Diagnostics
NVIDIA —Durham, NC
- $224,000 - $356,500 a year
- Full-time
- Computer science
- Computer Science
- Software troubleshooting
Senior Staff Engineer
Infineon Technologies AG —Morrisville, NC
- $129,600 - $178,200 a year
- Hybrid work
- Background check
- 5 years
- Pass drug screening
Senior Validation Specialist
Katalyst Healthcares & Life Sciences —Raleigh, NC
- Contract
- 5 years
- Engineering
- Mentoring
Quick Apply
10d

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Senior Validation Engineer

PSC Biotech -
Durham, NC

Apply Now

Job Details

Full-time
14 days ago

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Pet insurance

Qualifications

Data integrity assurance
GAMP
Content creation for technical audiences
Laboratory equipment performance testing and validation
Technical documentation
Pharmaceutical regulatory compliance
Laboratory instrument validation
FDA 21 CFR Part 11
Data integrity and documentation
Quality risk management
Pharmaceutical company experience
Laboratory compliance
Compliance documentation
Biomedical regulatory compliance
Technical project management
Commissioning phase involvement
Technical writing experience within technology
Cross-functional collaboration
Project stakeholder communication
Cross-functional communication
Pharmaceutical manufacturing facility experience
Stakeholder management
Engineering quality assurance

Full Job Description

Job Information

Date Opened 08/20/2026
Job Type Full time
Industry Pharma
City Durham
State/Province North Carolina
Country United States

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are seeking an experienced Senior Validation Engineer to support commissioning, qualification, and validation activities for laboratory equipment, computerized systems, and analytical instrumentation within a regulated pharmaceutical or biotechnology environment. This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity, and regulatory requirements.

Lead and execute commissioning, qualification, and validation activities for laboratory equipment, analytical instruments, utilities, and computerized systems.
Develop, review, and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
Author, execute, and review validation documentation within the KNEAT platform.
Support Computer System Validation (CSV) activities.
Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle.
Collaborate with cross-functional stakeholders to ensure validation activities are executed on schedule and in compliance with site procedures.
Support deviation investigations, CAPAs, change controls, and impact assessments associated with validation activities.
Provide technical leadership and mentorship to junior validation engineers and project team members.
Support internal audits, client audits, and regulatory inspections as needed.
Ensure all validation documentation is complete, accurate, and inspection-ready.

Requirements

Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline.
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
Demonstrated experience with laboratory equipment qualification and analytical instrument validation.
Strong Computer System Validation (CSV) experience supporting regulated computerized systems.
Hands-on experience using KNEAT for protocol development, execution, review, approval, and lifecycle management.
Extensive knowledge of validation lifecycle activities, including:
- Risk Assessments
- Validation Plans
- IQ/OQ/PQ Execution
- Traceability Management
- Validation Reporting
- Change Control
- Deviation Management
Thorough understanding of cGMP regulations, FDA requirements, GAMP 5, 21 CFR Part 11, and data integrity principles.
Strong technical writing and documentation skills.
Ability to independently manage complex validation projects in a fast-paced environment.
Excellent communication, stakeholder management, and cross-functional collaboration skills.
Experience supporting regulatory inspections and audit readiness activities preferred.
Must be authorized to work in the U.S. No C2C at this time.

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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Refine Your Search

senior validation engineer jobs in holly springs, nc

Senior Validation Engineer

Senior Data Engineer

Senior Manufacturing Systems Engineer

Senior ETL Test Engineer

Senior Data Engineer

Senior Principal Mechanical Engineer

Senior Vision Software Engineer (R&D)

Sr. Hardware Design Engineer

Sr. Software Dev Engineer Test

Sr Engineer 1, Process Validation

Senior Validation Engineer

Senior Principal Engineer, Inspection

Senior Security Engineer

Data/Senior Data & Analytics Engineer (PI, MQTT and UNS)

Senior Manufacturing Systems Engineer – DeltaV

Senior Project Engineer Clean Utilities

Senior Process Engineer - Solution Prep, Upstream, and Downstream

Senior System Software Engineer – Data Center Compute Diagnostics

Senior Staff Engineer

Senior Validation Specialist

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