Validation Engineer Jobs in Pennsylvania
Validation Engineer jobs in Pennsylvania are consistently active, with strong demand concentrated in pharmaceutical manufacturing, medical device production, and life sciences research across a seniority range from entry-level quality associates through senior validation specialists. The Philadelphia metro, Pittsburgh, and the Lehigh Valley account for the largest share of openings, anchored by established employers such as GlaxoSmithKline, West Pharmaceutical Services, and Johnson and Johnson's Pennsylvania operations. Computer system validation, process validation for FDA-regulated environments, and equipment qualification are the most sought-after specialties in the state. Find a role that fits below and apply directly.
Find Validation Engineer JobsOverview
Showing 5 of 19+ Validation Engineer jobs
Validation Engineer
Location: Hybrid/Remote: The successful candidate can work on a Hybrid/Remote basis, reporting into one of our offices located in Pennsylvania or North Carolina.
Status: Permanent
Package: Competitive Salary, Remote/Home Working (with one-off allowance), Flexible Working, (2 Days in the office for our Hybrid workers) Development & Opportunity (Personal & Technical), Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Long Term & Short-Term Disability Insurance, Generous 401K (matching) Plan, Flexible Spending Account, Health Savings Account, 15 Days' Vacation + Plus Public Holidays + Buy and Sell Scheme.
d-wise, an Instem company, designs, deploys, and supports validated cloud infrastructure for life-sciences and clinical trial organizations. Our flagship product, Accel, is a turn-key, validated Statistical Computing Environment (SCE) built on AWS and pre-loaded with SAS, R, Python, and Posit tools; giving biostatisticians and clinical programmers a secure, compliant, and high-performance environment for clinical data analysis and regulatory submission.
The Validation Engineer provides validation and compliance services to internal and external clients, ensuring that Instem software and systems meet regulatory requirements and industry standards. The role delivers validation activities across multiple projects, from technical advice, audits and requirements and risk assessments through to test execution. It also plays an active part in shaping how Instem performs validation, championing risk-based approaches and identifying and implementing opportunities to automate validation testing and improve efficiency.
Our Culture & Work Environment.
You’ll be part of a friendly, solutions-focused environment within a global business of over 400 people. Here, you’ll experience a high-performance culture balanced with genuine flexibility - we trust you to take ownership, deliver meaningful results, and work in a way that suits you.
You’ll be encouraged to grow, share your ideas, and make a real impact. We’re passionate about creating a place where you can develop your skills, contribute confidently, and succeed in your career.
Why join us as a Validation Engineer?
This role is an opportunity for you to shape how we do validation here at Instem, if you are looking for a role where you can shape, define and change processes in validation, this could be a perfect role for you!
What You’ll Be Doing
Validation Activities:
- Validation exercises for internal and external clients:
o Organizing remote system access.
o Assessing risks and advising on mitigation activities.
o Execution: Producing documentary evidence that fulfils the planned requirements, including regulatory-acceptable execution of manual and automated tests.
o Reporting: Documenting the executed activities, summarizing findings and advising on next steps.
- Detailed fault/deviation analysis and resolution planning.
- Facilitation of Change/Risk Assessment and other validation support activities.
- Support the resourcing and scheduling of validation projects and activities.
- Maintenance of Work Instructions for identified processes and tools.
Validation Approach Definition:
- Help define and evolve Instem’s validation methodology and standards, including risk-based approaches aligned with current industry guidance.
- Identify validation activities suitable for automation, prioritizing by feasibility, effort and expected benefit.
- Design, develop and maintain automated validation tests and frameworks that remain fit for purpose in a GxP context (e.g. tool assurance, evidence capture, data integrity).
- Analyze validation processes and deliverables to remove bottlenecks, duplication and rework, using measures such as cycle time, effort and deviation rates to demonstrate impact.
- Work with Development, QA and Product teams to align validation with the software development lifecycle, leveraging existing development testing where appropriate.
- Pilot new tools and techniques and support their adoption across the team through guidance and training.
Documentation & Reporting:
- Creation of “typical workflow” diagrams or documentation to support requirements analysis.
- Development, maintenance and review of client-facing UAT test scripts.
- Creation and maintenance of Test Evidence packages, including analysis of content extracted from Azure DevOps, automating their production where possible.
- Creation and maintenance of source material and templates in Instem’s Document Management System.
- Review updated Validation Support Package materials for content, coverage, accuracy and formatting against product functionality, system specifications and client requirements.
Client Support:
- Collaborate with internal teams and clients to understand validation requirements and advise on efficient, risk-based approaches, including how automation and Instem’s validation materials can reduce their effort.
- Participate in client meetings and audits as needed.
Compliance & Quality:
- Stay current with regulatory requirements, industry trends and best practice in validation and quality assurance.
- Champion continuous improvement, ensuring changes to validation methods remain compliant and are documented, reviewed and approved.
- Adherence to the Company’s Quality Management System to ensure that all work is handled Securely, Professionally and Diligently.
What We’re Looking For
- Experience in the validation of computer and software systems within a GxP environment
- Knowledge of industry standards such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5, etc…
- Experience with test automation tools (e.g. Selenium, Playwright) and/or scripting (e.g. Python, PowerShell) is a plus
- Familiarity with Azure DevOps or similar application lifecycle management tools
- Demonstrable experience of process improvement, ideally in a regulated environment
- Good knowledge of Microsoft Office products
Ready to Make a Difference?
Join a team that values your perspective and supports your growth, while helping shape the future of life sciences. Apply now - we’d love to hear from you, and our Talent team will be in touch.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/
#LI-KL #LI-HYBRID
Validation Engineer
Location: Hybrid/Remote: The successful candidate can work on a Hybrid/Remote basis, reporting into one of our offices located in Pennsylvania or North Carolina.
Status: Permanent
Package: Competitive Salary, Remote/Home Working (with one-off allowance), Flexible Working, (2 Days in the office for our Hybrid workers) Development & Opportunity (Personal & Technical), Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Long Term & Short-Term Disability Insurance, Generous 401K (matching) Plan, Flexible Spending Account, Health Savings Account, 15 Days' Vacation + Plus Public Holidays + Buy and Sell Scheme.
d-wise, an Instem company, designs, deploys, and supports validated cloud infrastructure for life-sciences and clinical trial organizations. Our flagship product, Accel, is a turn-key, validated Statistical Computing Environment (SCE) built on AWS and pre-loaded with SAS, R, Python, and Posit tools; giving biostatisticians and clinical programmers a secure, compliant, and high-performance environment for clinical data analysis and regulatory submission.
The Validation Engineer provides validation and compliance services to internal and external clients, ensuring that Instem software and systems meet regulatory requirements and industry standards. The role delivers validation activities across multiple projects, from technical advice, audits and requirements and risk assessments through to test execution. It also plays an active part in shaping how Instem performs validation, championing risk-based approaches and identifying and implementing opportunities to automate validation testing and improve efficiency.
Our Culture & Work Environment.
You’ll be part of a friendly, solutions-focused environment within a global business of over 400 people. Here, you’ll experience a high-performance culture balanced with genuine flexibility - we trust you to take ownership, deliver meaningful results, and work in a way that suits you.
You’ll be encouraged to grow, share your ideas, and make a real impact. We’re passionate about creating a place where you can develop your skills, contribute confidently, and succeed in your career.
Why join us as a Validation Engineer?
This role is an opportunity for you to shape how we do validation here at Instem, if you are looking for a role where you can shape, define and change processes in validation, this could be a perfect role for you!
What You’ll Be Doing
Validation Activities:
- Validation exercises for internal and external clients:
o Organizing remote system access.
o Assessing risks and advising on mitigation activities.
o Execution: Producing documentary evidence that fulfils the planned requirements, including regulatory-acceptable execution of manual and automated tests.
o Reporting: Documenting the executed activities, summarizing findings and advising on next steps.
- Detailed fault/deviation analysis and resolution planning.
- Facilitation of Change/Risk Assessment and other validation support activities.
- Support the resourcing and scheduling of validation projects and activities.
- Maintenance of Work Instructions for identified processes and tools.
Validation Approach Definition:
- Help define and evolve Instem’s validation methodology and standards, including risk-based approaches aligned with current industry guidance.
- Identify validation activities suitable for automation, prioritizing by feasibility, effort and expected benefit.
- Design, develop and maintain automated validation tests and frameworks that remain fit for purpose in a GxP context (e.g. tool assurance, evidence capture, data integrity).
- Analyze validation processes and deliverables to remove bottlenecks, duplication and rework, using measures such as cycle time, effort and deviation rates to demonstrate impact.
- Work with Development, QA and Product teams to align validation with the software development lifecycle, leveraging existing development testing where appropriate.
- Pilot new tools and techniques and support their adoption across the team through guidance and training.
Documentation & Reporting:
- Creation of “typical workflow” diagrams or documentation to support requirements analysis.
- Development, maintenance and review of client-facing UAT test scripts.
- Creation and maintenance of Test Evidence packages, including analysis of content extracted from Azure DevOps, automating their production where possible.
- Creation and maintenance of source material and templates in Instem’s Document Management System.
- Review updated Validation Support Package materials for content, coverage, accuracy and formatting against product functionality, system specifications and client requirements.
Client Support:
- Collaborate with internal teams and clients to understand validation requirements and advise on efficient, risk-based approaches, including how automation and Instem’s validation materials can reduce their effort.
- Participate in client meetings and audits as needed.
Compliance & Quality:
- Stay current with regulatory requirements, industry trends and best practice in validation and quality assurance.
- Champion continuous improvement, ensuring changes to validation methods remain compliant and are documented, reviewed and approved.
- Adherence to the Company’s Quality Management System to ensure that all work is handled Securely, Professionally and Diligently.
What We’re Looking For
- Experience in the validation of computer and software systems within a GxP environment
- Knowledge of industry standards such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5, etc…
- Experience with test automation tools (e.g. Selenium, Playwright) and/or scripting (e.g. Python, PowerShell) is a plus
- Familiarity with Azure DevOps or similar application lifecycle management tools
- Demonstrable experience of process improvement, ideally in a regulated environment
- Good knowledge of Microsoft Office products
Ready to Make a Difference?
Join a team that values your perspective and supports your growth, while helping shape the future of life sciences. Apply now - we’d love to hear from you, and our Talent team will be in touch.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/
#LI-KL #LI-HYBRID
See All 19 Validation Engineer Jobs in Pennsylvania
Find roles in Pennsylvania that match your experience and apply in just a few clicks.
Find Validation Engineer JobsValidation Engineer Jobs by City in Pennsylvania
Where Pennsylvania roles are concentrated, by current openings.
Validation Engineer Job Market in Pennsylvania
A snapshot from current Pennsylvania openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Technology & Software
- Consulting & Professional Services
- Manufacturing
What Pennsylvania Employers Look For
The qualifications that appear most often in validation engineer jobs across Pennsylvania.
- Bachelor's degree in engineering, life sciences, or a closely related technical field
- Hands-on experience with FDA process validation protocols and IQ OQ PQ documentation
- Proficiency in computer system validation under 21 CFR Part 11 requirements
- Familiarity with GAMP 5 guidelines and risk-based validation methodologies
- Experience writing and executing validation protocols, reports, and change control documentation
- Strong working knowledge of cGMP regulations applicable to pharmaceutical or medical device manufacturing
Validation Engineer Jobs in Pennsylvania: Frequently Asked Questions
How do you become a validation engineer in Pennsylvania?
Most validation engineer roles in Pennsylvania require a bachelor's degree in chemical, mechanical, biomedical, or electrical engineering, or a life sciences discipline. Pennsylvania does not issue a state-specific license for validation engineers, so hiring is credential- and experience-driven. Certifications from the American Society for Quality, such as the Certified Quality Engineer or Certified Quality Auditor designation, carry real weight with Pennsylvania pharmaceutical and medical device employers and provide a concrete competitive edge.
Which companies hire validation engineers in Pennsylvania?
Employers hiring validation engineers in Pennsylvania right now include Katalyst Healthcares & Life Sciences, CAI, and CNH Industrial, based on current listings on Migrate Mate as of November 2026. Pennsylvania's dense concentration of FDA-regulated pharmaceutical manufacturers, contract development and manufacturing organizations, and medical device firms means validation engineering is one of the more stable technical disciplines in the state's job market.
Which Pennsylvania cities have the most validation engineer jobs?
Harrisburg, New Holland, and University Park have the most validation engineer openings in Pennsylvania. The Philadelphia metro dominates due to its historic concentration of pharmaceutical headquarters and life sciences campuses, while Pittsburgh draws demand from medical device and healthcare technology employers, and the Lehigh Valley benefits from a cluster of large drug manufacturing and packaging facilities that rely heavily on validation teams.
Are there remote validation engineer jobs in Pennsylvania?
Yes, but they're rare. Validation engineering is fundamentally a hands-on discipline requiring physical presence to execute equipment qualification, process validation runs, and facility walkthroughs. About 38% of validation engineer openings tied to Pennsylvania are remote or hybrid as of November 2026, and the remote share tends to be limited to computer system validation, documentation review, and regulatory writing tasks that can be performed off-site.
How can I get hired as a validation engineer in Pennsylvania with little or no experience?
The most realistic entry path is a quality or manufacturing associate role at a Pennsylvania pharmaceutical or medical device facility, where you gain direct GMP exposure before moving into validation. Large contract manufacturers and pharmaceutical companies operating in the Delaware Valley and Lehigh Valley regions regularly bring on new graduates for quality assurance associate and validation technician positions. Pursuing an ASQ Certified Quality Engineer credential early and building a portfolio of IQ OQ PQ documentation, even from academic or internship projects, significantly strengthens an entry-level application.
Where can I find and apply to validation engineer jobs in Pennsylvania?
You can find and apply to validation engineer jobs in Pennsylvania on Migrate Mate, which lists current Pennsylvania openings updated regularly. Search the listings, find roles that match your experience and location, and apply directly to the employers posting them.
See All 19 Validation Engineer Jobs in Pennsylvania
Find roles in Pennsylvania that match your experience and apply in just a few clicks.
Find Validation Engineer Jobs