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Computer System Validation Manager Jobs in New Hampshire

Lonza

Computer Systems Validation Engineer

Portsmouth, NH · On-site

$85 - $110/hr

Computer Systems Validation Engineer United States, Portsmouth (New Hampshire) Location: Portsmouth ... Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation ...

PCI Pharma Services

VALIDATION ENGINEER IV

Bedford, NH · On-site

... management to achieve all project deliverables. * Perform a periodic review of systems to monitor the validation status of the system as well as write and develop validation SOPs. * Help define ...

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Computer System Validation Manager information

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 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 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.

What are the most commonly searched types of Computer System Validation jobs in New Hampshire?

The most popular types of Computer System Validation jobs in New Hampshire are:

What are popular job titles related to Computer System Validation Manager jobs in New Hampshire?

For Computer System Validation Manager jobs in New Hampshire, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in New Hampshire look for?

The top searched job categories for Computer System Validation Manager jobs in New Hampshire are:

What cities in New Hampshire are hiring for Computer System Validation Manager jobs?

Cities in New Hampshire with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in New Hampshire as of August 2026, with employment types broken down into 90% Full Time, 9% Part Time, and 1% Contract. Highlights an 79% Physical, 3% Hybrid, and 18% Remote job distribution.

Computer Systems Validation Specialist

Lonza

Portsmouth, NH • On-site

Full-time

Re-posted 26 days ago

Key responsibilities

  • Assess new and changing computer systems to ensure compliance with company policies, procedures, and industry guidance.

  • Perform CSV qualification activities, review change requests and test scripts, and draft protocols and GMP documentation revisions.

  • Lead or oversee CSV projects, perform validation maintenance, and review engineering documents related to computer systems.

Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

24th of 86 rated pharmaceutical

Job description

Computer Systems Validation (CSV) Specialist

Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.

The Computer Systems Validation (CSV) Specialist helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members and will be involved as the QA CSV representative during small and large-scale projects.

What you will get:

  • A collaborative and inclusive work environment.

  • Opportunities for career growth and development.

  • Access to cutting-edge technologies and tools.

  • Competitive compensation and benefits package.

  • Supportive leadership and mentoring.

  • Commitment to ethical and sustainable practices.

Access to our full list of global benefits: https://www.lonza.com/careers/benefits

What you will do:

  • Perform all aspects of QMS process' - Change Control, Deviations, CAPAs.

  • Execute all responsibilities as CSV project lead for simple projects.

  • Oversee/perform all CSV qualification activities for DeltaV and Syncade systems.

  • Perform Validation Maintenance of computerized systems.

  • Review/Revise CSV SOPs.

  • Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc..)

  • Assist with audits and inspections.

What we are looking for

  • Bachelor's degree in computer science, engineering, or related field.

  • 3+ years experience in Computer Systems Validation and in a cGMP facility.

  • 1+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, DeltaV is preferred.

  • Experience leading projects and managing CAPAs and deviations.

  • Background in biotech, pharma, or medical device industry.

  • Strong attention to detail and ability to meet deadlines.

  • Ability to work independently and on-site in Portsmouth NH.

About Lonza:

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values-Collaboration, Accountability, Excellence, Passion, and Integrity-reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

What Lonza employees say

Pay

Benefits

Hours and flexibility

Workplace

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About Lonza

Sourced by ZipRecruiter

Industry

Biotechnology research and development and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Bern, KS, US

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