Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports) * Ability to work independently while collaborating with cross-functional teams * Strong documentation ...
Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports) * Ability to work independently while collaborating with cross-functional teams * Strong documentation ...
Validation summary reports * Ensure validation documentation complies with cGMP regulations and internal quality procedures. * Participate in system impact assessments, risk assessments, and ...
Quick apply
Validation summary reports * Ensure validation documentation complies with cGMP regulations and internal quality procedures. * Participate in system impact assessments, risk assessments, and ...
Experience working within digital validation platforms such as Kneat is highly desirable. This position requires an individual who can work independently while collaborating cross-functionally with ...
Experience working within digital validation platforms such as Kneat is highly desirable. This position requires an individual who can work independently while collaborating cross-functionally with ...
This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility ...
This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility ...
Validation summary reports * Ensure validation documentation complies with cGMP regulations and internal quality procedures. * Participate in system impact assessments, risk assessments, and ...
Validation summary reports * Ensure validation documentation complies with cGMP regulations and internal quality procedures. * Participate in system impact assessments, risk assessments, and ...
Sr/Principal Computer Systems Validation Specialist
Durham, NC · On-site
$133K - $183K/yr
Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and ...
Sr/Principal Computer Systems Validation Specialist
Durham, NC · On-site
$133K - $183K/yr
Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and ...
6243 - Downstream Principal CQV Engineer / Lead Validation Engineer
Holly Springs, NC · On-site
$107K - $168K/yr
Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports) * Ability to work independently while collaborating with cross-functional teams * Strong documentation ...
6243 - Downstream Principal CQV Engineer / Lead Validation Engineer
Holly Springs, NC · On-site
$107K - $168K/yr
Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports) * Ability to work independently while collaborating with cross-functional teams * Strong documentation ...
Sr/Principal Computer Systems Validation Specialist
Durham, NC · On-site
$133K - $183K/yr
Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls,CAPAs, and ...
Sr/Principal Computer Systems Validation Specialist
Durham, NC · On-site
$133K - $183K/yr
Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls,CAPAs, and ...
Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports) * Ability to work independently while collaborating with cross-functional teams * Strong documentation ...
Quick apply
Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports) * Ability to work independently while collaborating with cross-functional teams * Strong documentation ...
Drive equipment qualification & optimization, validation within area, quality of equipment & processes * Coach & mentor team members * Drive process monitoring activities for key process parameters ...
Drive equipment qualification & optimization, validation within area, quality of equipment & processes * Coach & mentor team members * Drive process monitoring activities for key process parameters ...
Business Development Manager- Commissioning, Qualification, Validation (CQV) - Remote from home
Raleigh, NC · On-site +1
It provides process engineering, process design, and commissioning - qualification - validation (CQV) services to pharmaceutical/biotechnology clients worldwide. For projects of every scale, we ...
Business Development Manager- Commissioning, Qualification, Validation (CQV) - Remote from home
Raleigh, NC · On-site +1
It provides process engineering, process design, and commissioning - qualification - validation (CQV) services to pharmaceutical/biotechnology clients worldwide. For projects of every scale, we ...
Drive equipment qualification & optimization, validation within area, quality of equipment & processes * Coach & mentor team members * Drive process monitoring activities for key process parameters ...
Drive equipment qualification & optimization, validation within area, quality of equipment & processes * Coach & mentor team members * Drive process monitoring activities for key process parameters ...
Drive equipment qualification & optimization, validation within area, quality of equipment & processes * Coach & mentor team members * Drive process monitoring activities for key process parameters ...
Drive equipment qualification & optimization, validation within area, quality of equipment & processes * Coach & mentor team members * Drive process monitoring activities for key process parameters ...
Sr Engineer, PD Process Validation & Business - Holly Springs, NC
Holly Springs, NC · On-site
$75K - $100K/yr
This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility ...
Sr Engineer, PD Process Validation & Business - Holly Springs, NC
Holly Springs, NC · On-site
$75K - $100K/yr
This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility ...
Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: NPI and MFG Systems Duration: 1+ year (with ...
Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: NPI and MFG Systems Duration: 1+ year (with ...
This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team. General CSV ...
New
This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team. General CSV ...
New
Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: NPI and MFG Systems Duration: 1+ year (with ...
Quick apply
Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: NPI and MFG Systems Duration: 1+ year (with ...
This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility ...
This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility ...
Experience using digital validation platforms such as Kneat * Experience supporting FAT/SAT, commissioning, and equipment startup * Familiarity with automated process systems and PLC-based equipment
Experience using digital validation platforms such as Kneat * Experience supporting FAT/SAT, commissioning, and equipment startup * Familiarity with automated process systems and PLC-based equipment
6244 - CIP (Clean-in-Place) CQV Engineer / Lead Validation Engineer
Apex, NC · On-site
$107K - $168K/yr
Experience using digital validation platforms such as Kneat * Experience supporting FAT/SAT, commissioning, and equipment startup * Familiarity with automated process systems and PLC-based equipment
6244 - CIP (Clean-in-Place) CQV Engineer / Lead Validation Engineer
Apex, NC · On-site
$107K - $168K/yr
Experience using digital validation platforms such as Kneat * Experience supporting FAT/SAT, commissioning, and equipment startup * Familiarity with automated process systems and PLC-based equipment
Validation information
See Raleigh, NC salary details
$21.97 - $26.87
2% of jobs
$26.87 - $31.78
6% of jobs
$31.78 - $36.69
13% of jobs
$38.22 is the 25th percentile. Wages below this are outliers.
$36.69 - $41.59
13% of jobs
$41.59 - $46.50
11% of jobs
The median wage is $48.95 / hr.
$46.50 - $51.41
12% of jobs
$51.41 - $56.31
9% of jobs
$60.10 is the 75th percentile. Wages above this are outliers.
$56.31 - $61.22
13% of jobs
$61.22 - $66.13
13% of jobs
$66.13 - $71.04
6% of jobs
$71.04 - $75.94
3% of jobs
$21
$50
$75
How much do validation jobs pay per hour?
What is the difference between Validation vs Quality Assurance?
| Aspect | Validation | Quality Assurance |
|---|---|---|
| Purpose | Ensures products meet specifications and intended use | Prevents defects through process improvements |
| Focus | Product-specific testing and verification | Process and system quality control |
| Activities | Design validation, process validation, equipment validation | Audits, process reviews, standards compliance |
| Timing | Before product release | Throughout production cycle |
Validation focuses on confirming that a product or process meets specified requirements before release, while Quality Assurance emphasizes maintaining quality standards throughout the production process to prevent defects. Both roles are essential in industries like pharmaceuticals and manufacturing, but they serve different stages of quality management.
What are the key skills and qualifications needed to thrive as a Validation Engineer, and why are they important?
What are some common challenges faced by professionals in validation roles, and how can they be overcome?
What are validation jobs?
- Computer System Validation
- Pharmaceutical Validation
- Remote Validation
- Verification And Validation Engineer
- From Home Remote Validation
- Commissioning Qualification Validation Cqv
- Biotech Validation
- Validation Engineer Biomedical
- Medical Device Validation Engineer
- Work From Home Computer System Validation Csv

Other
Posted 3 days ago
Job description
We are seeking a Downstream Principal CQV Engineer is responsible for overseeing the commissioning and qualification of downstream systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.
Downstream Principal CQV Engineer Responsibilities:Downstream System Leadership- Serve as the commissioning and qualification lead for Downstream systems (responsibilities described below).
- Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems.
- Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
- Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
- Engage with design engineers and SMEs to clarify system intent and operational requirements.
- Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.
- Create Commissioning Test Plans that translate design intent into testable steps.
- Coordinate with the Automation Team to incorporate all automation functional testing.
- Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.
- Develop Installation, Operational, and Qualification (IOQ) protocols.
- Prepare and submit summary reports documenting commissioning and qualification activities.
- Take custody of the system post-construction and maintain ownership through C&Q completion.
- Perform Lockout/Tagout (LOTO) for system safety.
- Conduct pre-startup safety checks and risk assessments.
- Prepare daily pre-task plans and verify team readiness for safe execution.
- Attend daily commissioning meetings to coordinate activities.
- Execute commissioning and IOQ protocols.
- Resolve issues arising during execution.
- Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline
- 10+ years of role specific experience
- Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments
- Hands-on experience with downstream bioprocess equipment and purification systems
- Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)
- Ability to work independently while collaborating with cross-functional teams
- Strong documentation, organizational, and communication skills
- Experience with digital validation systems such as Kneat
- Experience supporting FAT/SAT, commissioning, and equipment startup
- Familiarity with risk-based validation approaches
- Experience in biologics manufacturing or monoclonal antibody production environments
- Onsite job requirement in Holly Springs, NC
About Verista
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Fishers, IN, US
Year founded
2020