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Computer System Validation Manager Jobs in North Carolina

ALLIANCE BIOTECH SOLUTIONS LLC

CSV Engineer

Raleigh, NC · On-site

The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms ...

New

Alliance Biotech Solutions LLC

CSV Engineer

Raleigh, NC · On-site

The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms ...

New

Novartis

Validation Lead

Durham, NC · On-site

$126K - $234K/yr

Strong knowledge of quality systems applied statistics, and global regulatory requirements. * Demonstrated success managing complex cross-functional projects and authoring technical validation ...

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Computer System Validation Manager information

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

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Computer System Validation Manager jobs near you
Engineer III, Computer Systems Validation

Engineer III, Computer Systems Validation

Thermo Fisher Scientific

Greenville, NC

Full-time

Re-posted 21 days ago

Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 415 frontline employees who took The Breakroom Quiz

196th of 528 rated manufacturers

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges.

Description:

Join our validation engineering team as a Validation Engineer III (Computer Systems Validation – CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.

In this role, you will lead and execute validation activities with a strong focus on automation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements.

You will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits. This role requires a high level of independence, technical expertise, and the ability to lead complex validation efforts.

A Day in the Role:

  • Lead validation activities for equipment, processes, utilities, and computer systems, with emphasis on CSV

  • Evaluate and support change management for existing manufacturing systems and automation platforms

  • Author, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans

  • Perform and lead risk assessments, gap analyses, and validation assessments

  • Collaborate with automation engineers on systems such as PLC, SCADA, DCS, DeltaV, and Allen-Bradley platforms

  • Independently manage validation projects and coordinate cross-functional teams

  • Provide technical expertise during regulatory inspections and client audits

  • Mentor junior team members and support knowledge sharing across the team

  • Contribute to continuous improvement and operational excellence initiatives

Requirements:

  • Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field

Equivalency:
Equivalent combinations of education, training, and relevant experience may be considered in place of a degree

  • Minimum of 4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industry

  • Strong knowledge of cGMP regulations (FDA, EMA, ISO)

  • Experience with Computer Systems Validation (CSV), CQV, or automation validation

  • Experience writing and executing IQ/OQ/PQ validation protocols

  • Experience with automation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)

  • Proven ability to lead validation projects and work cross-functionally

  • Strong technical writing and documentation skills

  • Experience with risk assessment methodologies and statistical analysis

  • Advanced problem-solving and root cause analysis skills

  • Excellent verbal and written communication skills

  • Proficiency with MS Office and validation-related systems

Preferred:

  • Experience supporting or contributing to capital (CapEx) projects

  • Experience with regulatory inspections and client audits

  • Knowledge of lean manufacturing and continuous improvement methodologies

Additional Information:

  • Ability to work in cleanroom environments as required

  • Flexibility to support extended hours or off-shift work during project activities or shutdowns

  • May require up to 25% travel

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