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Computer System Validation Manager Jobs in New Hampshire

TekWissen LLC

Senior Validation Engineer

Portsmouth, NH · On-site

$35 - $45/hr

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that ... Perform risk assessments on computerized systems * Review and approve change requests, validation ...

Biopharma Careers

Systems Engineer (R2-R4)

Concord, NH · On-site

$89 - $103/hr

... management and user adoption strategies for large-scale system implementations; 1 year of experience with computer system validation, including generation of testing artifacts for MES; 1 year of ...

New

Lonza

Operations Technology Manager

Portsmouth, NH · On-site

Enforce strict adherence to cGMP regulations, data integrity, and system validation. * Team ... Bachelor's of Science Engineering (Computer Science,ITor related field Engineering, Computer ...

Lonza

Operations Technology Manager

Portsmouth, NH · On-site

Enforce strict adherence to cGMP regulations, data integrity, and system validation. * Team ... Bachelor's of Science Engineering (Computer Science, IT or related field Engineering, Computer ...

Lonza

Operations Technology Manager

Portsmouth, NH · On-site

$120 - $150/hr

Enforce strict adherence to cGMP regulations, data integrity, and system validation. Team ... Bachelor's of Science Engineering (Computer Science, IT or related field). * 10+ years experience ...

Lonza

Systems Development Engineer II

Portsmouth, NH · On-site

$90 - $120/hr

Coordinate MES patching, upgrades, and system validation testing in accordance with change control ... Associate's degree in Computer Science, Information Technology, a related field, or equivalent ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in New Hampshire

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.

Manufacturing Execution Systems Engineer

TekWissen LLC

Portsmouth, NH • On-site

Temporary

Posted 24 days ago

Job description

Overview:   

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title:       Manufacturing Execution Systems Engineer
Location:       Portsmouth, NH 03801
Duration:      6 Months
Job Type:      Temporary Assignment
Work Type:   Onsite
Shift:              1st Shift

Summary

Responsible for overseeing and executing MES validation activities related to the gLIMS implementation. This role ensures that all validation deliverables are completed on time and in full compliance with global guidelines, regulatory requirements, and quality standards. The position supports requirements gathering, testing, integration, and implementation of Manufacturing Execution Systems (MES) in conjunction with gLIMS and operates with a moderate level of supervision and autonomy.

Responsibilities

  • Lead gLIMS-MES interface validation activities and ensure timely completion, review, and approval of validation deliverables and documentation.
  • Collaborate with the Site Change Manager and Automation SME to update or replace impacted MES/LIMS SOPs and processes in alignment with global and local standards.
  • Work closely with gLIMS/MES leads, system users, and process owners to develop and revise MES recipes supporting gLIMS interfacing.
  • Configure production recipes using object libraries as required.
  • Execute validation test scripts, including test design, execution, simulation, and documentation activities, under the guidance of the supervisor or Validation SME.
  • Ensure all validation activities comply with regulatory, quality, and cGMP requirements.
  • Support cross-functional teams during MES integration and implementation activities.
  • Perform additional duties and project activities as assigned.

Required Skills

  • Bachelor’s degree in a STEM field or Computer Science with relevant industry experience.
  • 5–10 years of experience in Automation, Validation, Quality Control, Pharmaceutical, or Biotech environments.
  • Should have hands on experience in systems integration role, connecting Syncade to other software tools like LabVantage LIMS (referred to as gLIMS) and or other systems.
  • Hands-on experience with MES, LIMS, or comparable manufacturing and laboratory systems.
  • Strong knowledge of Computerized System Validation (CSV) methodologies, validation templates, protocols, and SOPs.
  • Familiarity with GMP/cGMP regulations, quality systems, and regulatory compliance requirements.
  • Experience with deviations, change controls, CAPAs, OTNs, and TrackWise or similar quality management systems.
  • Understanding of process, equipment, cleaning, and computer system validation activities.
  • Proficiency with Microsoft Project, Word, Excel, and PowerPoint.
  • Strong project management, planning, organization, communication, and cross-functional collaboration skills.
  • Ability to manage multiple priorities and medium-to-large validation projects within established timelines.
  • Experience supporting gLIMS implementations or MES/LIMS integration projects.
  • Background in pharmaceutical manufacturing operations, quality systems, or automation projects.
  • Experience reviewing and approving validation protocols, test scripts, and summary reports.
  • Regulated pharmaceutical / biotechnology manufacturing environment
  • Cross-functional collaboration with Automation, Quality, Manufacturing, Validation, and IT teams
  • Combination of independent work and collaborative project execution

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.


TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.

TekWissen® is an equal opportunity employer supporting workplace diversity. 

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About TekWissen

Sourced by ZipRecruiter

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Industry

Recruiting and staffing services

Company size

501 - 1,000 Employees

Headquarters location

Ann Arbor, MI, US

Year founded

2009

Social media

Twitter

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