Senior IT Validation Engineer
Kittery, ME · On-site
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer. * Systems Validation (especially for analytical computerized systems). * Works independently and in teams.
Kittery, ME · On-site
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer. * Systems Validation (especially for analytical computerized systems). * Works independently and in teams.
Kittery, ME · On-site
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer. * Systems Validation (especially for analytical computerized systems). * Works independently and in teams.
Kittery, ME · On-site
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer. * Systems Validation (especially for analytical computerized systems). * Works independently and in teams.
Kittery, ME · On-site
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer. * Systems Validation (especially for analytical computerized systems). * Works independently and in teams.
Bangor, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Bangor, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
South Portland, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
South Portland, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Bangor, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Bangor, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Augusta, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Augusta, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Augusta, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
Augusta, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
South Portland, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
South Portland, ME · On-site
$61K/yr
Identifying, analyzing, and resolving routine and technical issues affecting users, systems ... Performing computer projects, operational, or application-related assignments involving IT ...
$119K - $161K/yr
Performs root cause analysis on failed components and implements corrective measures. * Works with ... Critical professional related technical skills; computer skills: Proficient in Microsoft Office ...
$119K - $161K/yr
Performs root cause analysis on failed components and implements corrective measures. * Works with ... Critical professional related technical skills; computer skills: Proficient in Microsoft Office ...
Saco, ME · On-site
Performs root cause analysis on failed components and implements corrective measures. * Works with ... Critical professional related technical skills; computer skills: Proficient in Microsoft Office ...
Saco, ME · On-site
Performs root cause analysis on failed components and implements corrective measures. * Works with ... Critical professional related technical skills; computer skills: Proficient in Microsoft Office ...
Saco, ME · On-site
$109K - $149K/yr
Performs root cause analysis on failed components and implements corrective measures. * Works with ... Critical professional related technical skills; computer skills: Proficient in Microsoft Office ...
Saco, ME · On-site
$109K - $149K/yr
Performs root cause analysis on failed components and implements corrective measures. * Works with ... Critical professional related technical skills; computer skills: Proficient in Microsoft Office ...
Augusta, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Augusta, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Augusta, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Augusta, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
South Portland, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
South Portland, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
South Portland, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
South Portland, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Bangor, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Bangor, ME · On-site
$89K/yr
Performing computer projects, operational, or application-related assignments involving IT ... Applying systems analysis techniques, applications software development concepts and techniques ...
Waterboro, ME · On-site
Lead and/or requirements analysis, systems modeling, trade studies, requirements derivation, design ... Bachelor's degree in engineering (electrical, mechanical, computer or systems engineering) with two ...
Waterboro, ME · On-site
Lead and/or requirements analysis, systems modeling, trade studies, requirements derivation, design ... Bachelor's degree in engineering (electrical, mechanical, computer or systems engineering) with two ...
Lead and/or requirements analysis, systems modeling, trade studies, requirements derivation, design ... Bachelor's degree in engineering (electrical, mechanical, computer or systems engineering) with two ...
Lead and/or requirements analysis, systems modeling, trade studies, requirements derivation, design ... Bachelor's degree in engineering (electrical, mechanical, computer or systems engineering) with two ...
Augusta, ME · On-site
$44 - $59.75/hr
Responsibilities : • Conduct analysis of defined computer-oriented system problems and develop feasible solutions in accordance with industry standards. • Assess user requirements and translate ...
Augusta, ME · On-site
$44 - $59.75/hr
Responsibilities : • Conduct analysis of defined computer-oriented system problems and develop feasible solutions in accordance with industry standards. • Assess user requirements and translate ...
$16.29 - $19.68
7% of jobs
$19.68 - $23.06
8% of jobs
$23.06 - $26.45
6% of jobs
$26.98 is the 25th percentile. Wages below this are outliers.
$26.45 - $29.83
20% of jobs
The median wage is $31.77 / hr.
$29.83 - $33.22
15% of jobs
$33.22 - $36.60
6% of jobs
$36.60 - $39.99
5% of jobs
$43.37 is the 75th percentile. Wages above this are outliers.
$39.99 - $43.37
7% of jobs
$43.37 - $46.76
11% of jobs
$46.76 - $50.14
9% of jobs
$50.14 - $53.53
4% of jobs
$16
$35
$53
| Aspect | Computer Systems Analyst | Network Administrator |
|---|---|---|
| Credentials | Bachelor's degree in CS, IS, or related field; certifications like CompTIA, Cisco | Bachelor's degree in CS, IS, or related field; Cisco certifications, CompTIA Network+ |
| Work Environment | Office settings, consulting firms, IT departments | Data centers, office networks, IT support teams |
| Employer & Industry | Businesses, government agencies, consulting firms | Organizations with large or complex networks |
| Common Search & Comparison | Yes | Yes |
Computer Systems Analysts focus on evaluating and improving computer systems and software to meet business needs, often working on system design and implementation. Network Administrators primarily manage and maintain computer networks, ensuring connectivity and security. While both roles require similar certifications and work environments, their core responsibilities differ: analysts optimize systems, whereas administrators maintain network infrastructure.
A computer systems analyst helps companies increase efficiency through technology. They are responsible for examining and improving an organization’s computer systems and advising organization leaders on how to use technology to meet organizational goals and objectives. Computer systems analysts have education and experience in systems design, cost analysis, and computer science to develop technical solutions. To perform their jobs well, computer systems analysts must work with multiple departments including finance, quality assurance, information technology/technical support, and training to implement technical solutions that fit the budget, goals, and deliverables of the organization.

8.3
Based on 42 frontline employees who took The Breakroom Quiz
24th of 86 rated pharmaceutical
Computer Systems Validation Specialist III
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.
The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members.
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.
401(k) matching plan.
Supportive leadership and mentoring.
Commitment to ethical and sustainable practices.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do:
Perform all aspects of QMS process’ – Change Control, Deviations,
CAPAs.
Perform Gap assessments to identify the gaps in processes and suggest remediation plans. Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead for projects.
Author/Review/Approve all end to end Computer system validation life-
cycle deliverables/activities.
Schedule qualification activities and personnel to meet business,
manufacturing, engineering and quality objectives.
Revise and maintain SOPs to ensure continuous improvement and
compliance to GROUP/CORP procedures.
Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.).
Support Validation requests as a CSV SME, during Customer audits and inspections.
What we are looking for:
Bachelor’s degree in computer science, engineering, or related field.
At least 3+ years of experience in computer systems validation.
3+ years of Experience in working in a cGMP facility.
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer.
Systems Validation (especially for analytical computerized systems).
Works independently and in teams.
Background in biotech, pharma, or medical device industry.
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 of 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.
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