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Computer System Validation Manager Jobs in Manchester, NH

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 ...

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 ...

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

... Manager. Key Responsibilities: Finalize the Automation Validation Plan Work with a team of ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...

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

Integrated Resources INC

Quality Assurance

Andover, MA · On-site

... computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures. Candidate requires strong interpersonal, oral and written communication skills as ...

emplify GmbH

Staff Validation Engineer

Andover, MA · On-site

$120 - $150/hr

... MA seeks Staff Validation Engineer - Leading test planning, strategy, and documentation for ... systems, and manage and resolve verification roadblocks efficiently, engaging cross-functional ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Manchester, NH

Computer System Validation Manager information

See Manchester, NH salary details

$47.3K

$105K

$159.8K

How much do computer system validation manager jobs pay per year?

As of Sep 4, 2026, the average yearly pay for computer system validation manager in Manchester, NH is $104,959.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,200.00 and $131,400.00 per year, depending on experience, location, and employer.

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 Manchester, NH?

The most popular types of Computer System Validation jobs in Manchester, NH are:

What are popular job titles related to Computer System Validation Manager jobs in Manchester, NH?

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

What job categories do people searching Computer System Validation Manager jobs in Manchester, NH look for?

The top searched job categories for Computer System Validation Manager jobs in Manchester, NH are:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Manchester, NH as of August 2026, with employment types broken down into 75% Full Time, 10% Part Time, and 15% Contract. Highlights an 86% In-person, 5% Hybrid, and 9% Remote job distribution, with an average salary of $104,959 per year, or $50.5 per hour.

VALIDATION ENGINEER IV

PCI Pharma Services

Bedford, NH • On-site

Full-time

Re-posted 14 days ago

Key responsibilities

  • Author validation plans and oversee the development of specifications, test protocols, and validation reports for equipment, utilities, and processes.

  • Review and approve validation-related documentation, including system lifecycle documents, change controls, deviation reports, and validation protocols.

  • Coordinate and execute validation activities, providing guidance and communication with affected departments to ensure compliance and project deliverables.

PCI Pharma Services rating

6.3

Company rating: 6.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

492nd of 545 rated manufacturers

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
The Validation Engineer IV performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer provides guidance to internal project teams and external validation firms on large/complex validation/qualification initiatives and ensures project schedules are met. Complies with requirements of the Safety Program, including PCI Health and Safety mandates and OSHA requirements. In carrying out duties, contributes and promotes a positive and equitable working environment emphasizing the PCI Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
Essential Duties and Responsibilities:
  • Author validation plans; oversee and provide direction in the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ Protocols.
  • Review and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
  • Provide direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
  • Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project 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 validation strategies based on regulations, guidance documents, industry practice and experience.
  • Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation.
  • Team representative on validation projects leading by example on significant projects requiring complex technical solutions.
  • Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
  • Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities
  • Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated.
  • Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping team mates and manager informed and providing guidance to other engineers as needed.
  • Write protocols and technical study approaches.
  • Review document changes for validation impact.
  • Review deviation reports for validation impact.
  • Review and approval of change controls.
  • Propose corrective actions to validation manager and appropriate departments and implement the required changes.

Professional Skills:
  • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
  • Possess strong knowledge of commissioning, qualification validation and related practices, including applicable regulations.
  • Excellent technical writing, verbal communication and presentation skills.
  • Technical understanding of pharmaceutical/biotechnology unit operations.
  • Ability to evaluate compliance issues.
  • Strong skills in team development and leadership.
  • Successful demonstration of collaboration with validation management, and project teams.
  • Proficiency in Microsoft Office including Word, Excel, Power Point, Project

Qualities:
  • Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment.
  • Professional and collaborative team player must have strong interpersonal skills.
  • Honesty, integrity, respect and courtesy with all colleagues.
  • Ability to inspire others to strive for excellence.
  • Self-motivated and able to meet goals with minimal supervision.
  • TRAVEL - <15%

Qualifications:
  • Bachelor's degree in Engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience or combination of work experience in Validation, Quality, Production, or Engineering.
  • Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
  • Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
  • Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports.
  • Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Sterilization,
  • Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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