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Validation Engineer Jobs in Rochester, NY (NOW HIRING)

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Responsibilities will include, programing, reading, generating reports, as well as conducting routine maintenance per department procedure. Reviews documentation executed during validation activities ...

Validation Specialist Who we are? As a French pharmaceutical industrial group, we strive to make ... Your profile Education and Experience • Bachelor's degree in engineering, Life Sciences, or a ...

Collaborates cross-functionally with Operations, Engineering, Quality Assurance, Quality Control ... Maintains validation documentation in an organized and inspection-ready state to support internal ...

Responsibilities will include, programing, reading, generating reports, as well as conducting routine maintenance per department procedure. • Reviews documentation executed during validation ...

Summary The Validation Technician I is principally responsible for sample product assembly, environmental chamber testing, data capture, and laboratory organization. They follow validation standards ...

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Validation Engineer information

See Rochester, NY salary details

$22

$51

$77

How much do validation engineer jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for validation engineer in Rochester, NY is $51.62, according to ZipRecruiter salary data. Most workers in this role earn between $39.13 and $62.74 per hour, depending on experience, location, and employer.

Is validation engineer a good job?

Validation engineers are responsible for ensuring that products and processes meet quality standards through testing and documentation, often working in industries like pharmaceuticals, biotech, or manufacturing. The role typically requires knowledge of regulatory requirements, validation protocols, and tools like GxP or SOPs, and can offer stable employment with opportunities for advancement. Job satisfaction depends on individual interests in quality assurance, technical skills, and industry stability.

What degree do you need to be a validation engineer?

Validation engineers typically hold a bachelor's degree in engineering, life sciences, or a related field. Some roles may require a master's degree or specialized certifications in quality assurance or validation processes. Strong knowledge of regulatory standards and experience with validation tools are also important.

What is a validation engineer?

A validation engineer is responsible for testing equipment and electrical systems used in the manufacturing process. As a validation engineer, your primary duty is to work with the other members of the validation team to ensure that these systems measure up to company and industry standards. Skills needed for a validation engineer job include the ability to accurately test, measure, and calibrate manufacturing equipment for maximum efficiency and quality.

What is the difference between Validation Engineer vs Quality Assurance Engineer?

AspectValidation EngineerQuality Assurance Engineer
CertificationsGMP, ISO, Six SigmaISO, Six Sigma, CQA
Work EnvironmentRegulated industries like pharma, biotech, medical devicesManufacturing, software, and product development
Primary FocusEnsuring products meet specifications through validation processesPreventing defects through process and system improvements
Common UsageRegulatory compliance, validation protocolsProcess audits, quality systems

Validation Engineers focus on verifying that products and processes meet regulatory standards through validation protocols, especially in regulated industries. Quality Assurance Engineers concentrate on maintaining overall product quality by implementing and auditing quality systems. While both roles aim to ensure product safety and efficacy, Validation Engineers are more involved in validation activities, whereas QA Engineers focus on process improvement and defect prevention.

What are the key skills and qualifications needed to thrive as a validation engineer, and why are they important?

To thrive as a Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically backed by a degree in engineering or a related field. Familiarity with validation protocols, statistical analysis tools, and industry-specific regulations such as FDA, GMP, or ISO standards is essential. Strong analytical thinking, attention to detail, and effective communication set top performers apart in this role. These skills ensure that products and processes meet stringent quality and safety standards, minimizing risks and ensuring regulatory approval.

What are some common challenges validation engineers face when working cross-functionally with other departments?

Validation Engineers frequently collaborate with teams such as manufacturing, quality assurance, and research & development. One common challenge is aligning differing priorities and timelines between departments, which can sometimes delay validation projects. Effective communication skills and flexibility are crucial to navigating these cross-functional interactions, ensuring that all regulatory and quality requirements are met without hindering production schedules. Building strong working relationships and proactively addressing potential concerns can help Validation Engineers facilitate smoother project execution.
What are the most commonly searched types of Validation Engineer jobs in Rochester, NY? The most popular types of Validation Engineer jobs in Rochester, NY are:
What are popular job titles related to Validation Engineer jobs in Rochester, NY? For Validation Engineer jobs in Rochester, NY, the most frequently searched job titles are:
What job categories do people searching Validation Engineer jobs in Rochester, NY look for? The top searched job categories for Validation Engineer jobs in Rochester, NY are:
What cities near Rochester, NY are hiring for Validation Engineer jobs? Cities near Rochester, NY with the most Validation Engineer job openings:
Infographic showing various Validation Engineer job openings in Rochester, NY as of August 2026, with employment types broken down into 92% Full Time, and 8% Contract. Highlights an 100% In-person job distribution, with an average salary of $107,364 per year, or $51.6 per hour.

Validation Engineer

Stark Pharma Solutions Inc

Rochester, NY • On-site

Contractor

Posted 18 days ago


Job description

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Validation Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: Validation Engineer
Location: Rochester, NY
Duration: Long Term

Position Overview

We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role will be responsible for equipment qualification, process validation, cleaning validation, utility validation, and computerized system validation while ensuring compliance with FDA regulations, cGMP, GAMP 5, and industry standards. The ideal candidate will possess strong technical documentation skills and collaborate effectively with cross-functional teams to support manufacturing and quality operations.

Key Responsibilities

  • Execute Equipment Qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
  • Develop, review, execute, and maintain validation protocols, test scripts, and final validation reports.
  • Support Process Validation, Cleaning Validation, Utility Validation, and Computer System Validation (CSV) activities.
  • Perform risk assessments using FMEA and support validation lifecycle management.
  • Ensure validation documentation complies with FDA, cGMP, GAMP 5, 21 CFR Part 11, and company quality standards.
  • Investigate validation deviations, support CAPA implementation, and perform root cause analysis.
  • Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs teams to execute validation projects.
  • Review engineering documentation including URS, FS, DS, SOPs, P&IDs, and equipment specifications.
  • Support equipment commissioning, startup, qualification, and process improvement initiatives.
  • Maintain Validation Master Plans (VMP), validation schedules, and project documentation.
  • Participate in internal audits, customer audits, and regulatory inspections.
  • Identify opportunities to improve validation processes, documentation, and compliance activities.

Required Qualifications

  • Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutical Engineering, or a related engineering discipline.
  • 2+ years of validation experience within the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience with Equipment Qualification (IQ/OQ/PQ), Process Validation, Cleaning Validation, Utility Validation, or Computer System Validation (CSV).
  • Strong understanding of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, and data integrity requirements.
  • Experience developing, executing, and reviewing validation protocols and reports.
  • Familiarity with deviation investigations, CAPA, change control, and risk assessment methodologies.
  • Experience working in GMP-regulated manufacturing environments.
  • Strong technical writing, analytical, and problem-solving skills.
  • Excellent communication and cross-functional collaboration abilities.
  • Experience with validation management systems such as TrackWise, Kneat, Veeva, DeltaV, SCADA, PLC, or similar platforms is preferred.
  • Knowledge of Lean Manufacturing, continuous improvement, and commissioning & qualification (CQV) practices is an added advantage.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates:
https://www.linkedin.com/company/99455976/