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Computer System Validation Director Jobs in Lewes, DE

Merck & Co.

Digital Quality Product Line Lead

Millsboro, DE · On-site

$142K - $224K/yr

Ensure adherence to GxP regulations, Computer System Validation (CSV), and the transition toward CSA / OneCQV-aligned approaches. * Act as the primary IT partner for Quality and Lab leadership ...

New

MSD

Digital Quality Product Line Lead

Millsboro, DE · On-site

$142K - $224K/yr

Ensure adherence to GxP regulations, Computer System Validation (CSV), and the transition toward CSA / OneCQV-aligned approaches. * Act as the primary IT partner for Quality and Lab leadership ...

Pennoni

Civil CAD Technician

Milton, DE · On-site

In particular, we are looking for a CAD Technician to join our team on a full-time, direct basis at ... possess a Valid Driver's License. Preferred Qualifications: * Associate's degree in Civil ...

Pennoni

Civil CAD Technician

Milton, DE · On-site

In particular, we are looking for a CAD Technician to join our team on a full-time, direct basis at ... possess a Valid Driver's License. Preferred Qualifications: * Associate's degree in Civil ...

Davis Bowen Friedel

CAD Technician

Milford, DE · On-site

$20 - $32/hr

... related systems and structures. * Perform analyses and calculations according to project ... Two (2) years of direct work utilizing Carlson Precision 3D or Civil 3D, and construction drawing ...

Davis Bowen Friedel

CAD Technician

Milford, DE · On-site

$20 - $32/hr

... related systems and structures. * Perform analyses and calculations according to project ... Two (2) years of direct work utilizing Carlson Precision 3D or Civil 3D, and construction drawing ...

Davis Bowen Friedel

CAD Technician

Milford, DE · On-site

$20 - $32/hr

... related systems and structures. * Perform analyses and calculations according to project ... Two (2) years of direct work utilizing Carlson Precision 3D or Civil 3D, and construction drawing ...

Kindly Direct Care

Direct Support Professional

Cape May, NJ · On-site

$15 - $18.25/hr

Utilize electronic systems for scheduling, documentation, and communication * Comply with all ... Valid driver's license and reliable transportation * Ability to pass all required background checks ...

Atlas Restaurant Group

Host

Rehoboth Beach, DE · On-site

... computer system, answer the phones and fill to-go orders, show guests to their table and wish ... Must have a valid form of identification. MATHEMATICAL SKILLS: * Must have the knowledge to add ...

Atlas Restaurant Group

Host

Rehoboth Beach, DE · On-site

... computer system, answer the phones and fill to-go orders, show guests to their table and wish ... Must have a valid form of identification. MATHEMATICAL SKILLS: * Must have the knowledge to add ...

Atlas Restaurant Group

Host

Lewes, DE · On-site

... computer system, answer the phones and fill to-go orders, show guests to their table and wish ... Must have a valid form of identification. MATHEMATICAL SKILLS: * Must have the knowledge to add ...

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Computer System Validation Director information

See Lewes, DE salary details

$29

$51

$75

How much do computer system validation director jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for computer system validation director in Lewes, DE is $51.49, according to ZipRecruiter salary data. Most workers in this role earn between $38.70 and $64.04 per hour, depending on experience, location, and employer.

What is a computer system validation director?

Computer System Validation Directors oversee and manage the validation of computer systems within regulated industries, such as pharmaceuticals, biotechnology, or medical devices. Their primary responsibility is to ensure that all computer systems used for business and regulatory purposes comply with industry standards and regulatory requirements, such as FDA or EMA guidelines. They often lead validation teams, develop validation strategies and protocols, and work closely with IT, quality assurance, and compliance departments. This role is crucial to ensure data integrity, patient safety, and regulatory compliance throughout the system lifecycle.

What are the key skills and qualifications needed to thrive as a computer system validation director?

To thrive as a Computer System Validation Director, you need expertise in computer system validation (CSV), regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or IT. Familiarity with validation lifecycle management tools, quality management systems (QMS), and knowledge of industry standards like GAMP 5 are typically required. Strong leadership, project management, and communication skills are essential for leading cross-functional teams and ensuring clarity in compliance objectives. These skills are crucial to ensure validated systems meet regulatory requirements, minimize risk, and support organizational quality goals.

What are the main challenges a computer system validation director might face when leading validation projects across multiple global sites?

A Computer System Validation Director often encounters challenges such as navigating differing regulatory requirements across countries, coordinating cross-functional teams in various time zones, and ensuring consistent validation standards are maintained globally. Balancing project timelines with compliance demands can be difficult, especially when local teams have varying levels of validation experience. Strong communication, project management skills, and a deep understanding of international regulations are essential for overcoming these obstacles and ensuring successful, compliant system implementations.

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

AspectComputer System Validation DirectorValidation Manager
CredentialsTypically requires a Bachelor's or Master’s in Life Sciences, Engineering, or related fields; certifications like GxP, CSV certificationsSimilar credentials, often with additional certifications in validation or quality assurance
Work EnvironmentLeads validation teams in pharmaceutical, biotech, or medical device companies; strategic roleManages validation activities, oversees teams, and ensures compliance at operational levels
Industry UsageUsed across regulated industries for high-level validation oversightCommonly used in the same industries for day-to-day validation management

The main difference is that the Computer System Validation Director holds a strategic, leadership role overseeing validation programs, while the Validation Manager handles daily validation activities and team management. Both roles require similar credentials and are vital in regulated industries like pharma and biotech.

Infographic showing various Computer System Validation Director job openings in Lewes, DE as of August 2026, with employment types broken down into 72% Full Time, and 28% Contract. Highlights an 100% In-person job distribution, with an average salary of $107,101 per year, or $51.5 per hour.

GMP QC Systems Consultant

Frankford, DE • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 20 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on GMP QC Systems Consultant position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: GMP QC Systems Consultant

Location: Frankford, DE (100% Onsite)
Duration: 12+ Month Contract

Job Overview

We are seeking an experienced GMP QC Systems Consultant to support the implementation, integration, and validation of Quality Control laboratory systems in a regulated pharmaceutical environment. The ideal candidate will have strong expertise in GMP laboratory systems, Computer System Validation (CSV/CSA), and cross-functional project execution.

Key Responsibilities

  • Lead implementation and integration of GMP QC laboratory systems.
  • Coordinate system configuration, data migration, deployment, and go-live activities.
  • Manage project timelines, risks, budgets, and stakeholder communications.
  • Support Computer System Validation (CSV/CSA), including IQ/OQ/PQ execution and documentation.
  • Perform risk assessments, testing, and validation activities in compliance with GAMP5 and GxP requirements.
  • Collaborate with QA, IT, laboratory teams, vendors, and business stakeholders to ensure successful project delivery.
  • Ensure compliance with GxP, Data Integrity, and internal quality standards.
  • Prepare project status reports and support release readiness activities.

Required Qualifications

  • 8+ years of experience in Pharmaceutical, Biotechnology, or other GMP-regulated environments.
  • Strong experience implementing and validating QC/Laboratory systems.
  • Hands-on knowledge of CSV, CSA, GAMP5, GxP, IQ/OQ/PQ, and risk-based validation.
  • Experience with system integration, data migration, and cross-functional project coordination.
  • Familiarity with laboratory platforms such as LIMS, SDMS, Empower, LabX, QuantStudio, SoftMax Pro, or similar systems.
  • Excellent communication, documentation, and stakeholder management skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com