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Process Validation Jobs (NOW HIRING)

Dexian DISYS

Processor Validation Engineer

San Jose, CA · On-site

$80 - $85/hr

Processor Validation Engineer San Jose, CA: 100% Onsite 6 + Months $80-$85/HR Role: Validate and debug processor interfaces. Responsibilities: Execute test plans and debug issues Use lab tools ...

Dexian

Processor Validation Engineer

Campbell, CA · On-site

$80 - $85/hr

Processor Validation Engineer San Jose, CA: 100% Onsite 6 + Months $80-$85/HR Role: Validate and debug processor interfaces. Responsibilities: Execute test plans and debug issues Use lab tools ...

Peregrine Team

Validation Engineer

Philadelphia, PA · On-site

Peregrine Team is hiring a Validation Engineer to support equipment and process validation within a regulated pharmaceutical environment. This role ensures compliance with regulatory standards and ...

BioPhase Solutions

Validation Engineer

Los Angeles, CA

$115K/yr

Execute Process Validation and Cleaning Validation: Identify critical process parameters, establish validation protocols, and conduct cleaning validations to maintain product quality and regulatory ...

Validation & Engineering Group, Inc

PR · On-site

Perform process validation activities related to sterile manufacturing, including media fills (APS). * Ensure compliance with cGMP, FDA, EMA, and ICH guidelines. * Support commissioning and ...

Validation & Engineering Group, Inc

PR · On-site

Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity. Documentation & Compliance: * Generate and review URS, FAT/SAT, IOQ, and PQ documentation ...

kindeva

Validation Engineer II

Saint Louis, MO

This role assists with equipment qualification, aseptic process validation, cleaning validation, computer systems validation, and inspection/packaging validation activities. The position delivers ...

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How much do process validation jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for process validation in the United States is $39.54, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $51.44 per hour, depending on experience, location, and employer.

What is process validation?

Process validation is a documented procedure used in industries, especially pharmaceuticals and manufacturing, to ensure that a process consistently produces a product meeting its predetermined specifications and quality attributes. It involves planning, conducting, and analyzing studies that provide evidence the process is reliable and reproducible. Regulatory agencies like the FDA require process validation to guarantee product safety and efficacy. Process validation typically includes design, qualification, and continued monitoring stages. This ensures that any variations in the process do not affect the final product's quality.

What are some common challenges faced by professionals in Process Validation, and how can they be addressed?

Professionals in Process Validation often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and resolving unexpected deviations during validation runs. Effective communication with cross-functional teams—such as Quality Assurance, Manufacturing, and R&D—can help address these issues quickly. Staying proactive with documentation, maintaining a robust risk assessment process, and continually updating knowledge on industry regulations are key strategies to overcoming these challenges and ensuring successful validation outcomes.

What are the key skills and qualifications needed to thrive as a Process Validation Specialist, and why are they important?

To thrive as a Process Validation Specialist, you need a strong background in engineering, life sciences, or a related field, along with expertise in validation protocols and regulatory guidelines such as GMP. Familiarity with validation software, data analysis tools, and documentation systems like LIMS is typically required, and certifications such as Six Sigma or ASQ may be advantageous. Attention to detail, analytical thinking, and effective communication are crucial soft skills for this role. These skills ensure that manufacturing processes consistently produce products that meet quality standards and regulatory compliance, which is essential for patient safety and product efficacy.

What is the difference between Process Validation vs Quality Assurance Specialist?

AspectProcess ValidationQuality Assurance Specialist
CredentialsGMP, ISO certifications, technical trainingGMP, ISO certifications, auditing training
Work EnvironmentManufacturing, pharmaceutical, biotech facilitiesQuality departments, manufacturing sites
Employer & Industry UsageUsed in regulated industries to ensure process consistencyEnsures product quality through audits and compliance

Process Validation focuses on confirming that manufacturing processes consistently produce quality products, while Quality Assurance Specialists oversee overall quality systems, audits, and compliance. Both roles are essential in regulated industries but serve different functions in maintaining product integrity.

More about Process Validation jobs
What cities are hiring for Process Validation jobs? Cities with the most Process Validation job openings:
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What job categories do people searching Process Validation jobs look for? The top searched job categories for Process Validation jobs are:
Process Validation jobs near you
Infographic showing various Process Validation job openings in the United States as of June 2026, with employment types broken down into 2% Locum Tenens, 23% Full Time, 72% Part Time, 2% Temporary, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $82,237 per year, or $39.5 per hour.
Validation Process Engineer

Validation Process Engineer

Catalent, Inc.

Kansas City, MO • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Catalent rating

7.7

Company rating: 7.7 out of 10

Based on 50 frontline employees who took The Breakroom Quiz

45th of 71 rated pharmaceutical

Job description

Validation Process Engineer
Position Summary:
  • Work Schedule: M-F 8am-4:30pm
  • 100% on-site

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.
Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The Validation Process Engineer supports GMP equipment and process validation activities from requirements definition and vendor selection through installation, qualification, and performance verification to ensure systems meet user needs and regulatory expectations. Manages capital projects (budget, timelines, FAT/SAT) while authoring and executing risk assessments, validation protocols, and controlled documentation (e.g., IQ/OQ/PQ, PPQ, VSR) and coordinating training for operations and maintenance. Supports commercial client onboarding owning process capability assessments, FEMAs, validation master plans, process performance qualifications and final product specifications. Provides technical support for change control, deviations/CAPA, audits, continuous improvement initiatives, and commercial client onboarding.
The Role:
  • Develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, and oversee build, and ensure that equipment meets functional requirements.
  • Submit capital requests and manage project budget/timelines to completion.
  • Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed.
  • Prepare/execute/review FMEAs, Risk Assessments, Performance Verifications (PV), Engineering Studies (ES), Validation Plans (VP), System Impact Assessments (SIA), Data Integrity Assessments (DIA), Requirement Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration Qualifications (CQ), and Process Performance Qualifications (PPQ).
  • Author Procedures and Work Instructions for equipment operation. Coordinate and train operations and maintenance personnel.
  • Perform periodic reviews and requalifications.
  • Participate in site safety team initiatives.
  • Participate in Gemba Walks, Kaizens, Lean Six Sigma, and other continuous improvement projects/initiatives.
  • Lead and/or provide technical support for management of change forms (MOCs), deviations, change controls, CAPAs and audit findings.
  • Provide validation support for the onboarding of commercial clients.
  • Perform other duties as assigned.

The Candidate:
  • BS Engineering or relevant science degree required.
  • 1 - 5 years of GMP process, equipment, and/or facility engineering validation experience.
  • Client facing project management experience a preferred.
  • Lean six sigma training/certification, preferred.
  • Demonstrated ability to write and execute technical documents and validation protocols in compliance with cGDP and cGMP requirements.
  • Ability to read, understand, and apply SOPs and regulatory requirements to perform daily tasks in a regulated manufacturing environment.
  • Strong communication and collaboration skills, including written and verbal communication, presenting to groups (virtual and in person), and working effectively as part of a team to develop solutions.
  • Strong organizational, problem-solving, and decision-making skills, with the ability to manage multiple priorities, work under pressure, and apply a working understanding of basic machine functionality (e.g., PLCs, servo motors, controls, pneumatics).
  • Physical Requirements: Ability to stand, walk, sit, kneel, and reach frequently, occasionally lift, push, and pull up to 25 lbs, and climb ladders or steps as needed, while working in environments with temperature variation (including refrigerated and freezer areas), noise, humidity, and potential hazards; role also requires successful completion of background and DEA screening and up to 5% travel for trade shows and factory acceptance testing.

Why you should join Catalent:
  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.

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About Catalent

Sourced by ZipRecruiter

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Somerset, NJ, US

Year founded

2007

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