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Process Validation Jobs (NOW HIRING)

Danaher

Senior Engineer, Process Validation

Houston, TX · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

Sunnyvale, CA · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

Raleigh, NC · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

Raleigh, NC · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

Boston, MA · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

Dallas, TX · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Danaher

Senior Engineer, Process Validation

Dallas, TX · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

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Process Validation information

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How much do process validation jobs pay per hour?

As of Aug 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.

What skills are needed for process validation?

Process validation professionals need strong analytical skills, attention to detail, and knowledge of manufacturing processes and quality systems. Familiarity with regulatory requirements such as GMP, validation protocols, and documentation practices is essential. Proficiency with data analysis tools and good communication skills are also important for successful validation activities.
More about Process Validation jobs
What states have the most Process Validation jobs? States with the most job openings for Process Validation jobs include:
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 August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $82,237 per year, or $39.5 per hour.

Process Validation Associate III

Simtra BioPharma Solutions

Bloomington, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 2 days ago

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra?Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
The role:
This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Process Validation Sr. Manager.
The responsibilities:
  • Support and maintain the process validation program.
  • Develop, revise, and maintain process validation procedures, protocols, and summary reports.
  • Partner with clients and internal teams to define validation scope, requirements, and objectives.
  • Design, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.
  • Perform risk assessments to support process validation activities.
  • Plan, coordinate, and execute process validation activities for new and existing products.
  • Analyze validation data and prepare documentation to support validation conclusions.
  • Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
  • Lead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
  • Monitor regulatory requirements and industry best practices to ensure compliance and continuous improvement.
  • Create and maintain visual management tools and controls for the Process Validation group.
  • Serve as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.
  • Develop industry expertise and project proficiency while working independently on assigned initiatives.
  • Identify and implement opportunities to optimize departmental processes and improve operational efficiency.

Required qualifications:
  • Bachelor's degree required, preferably in a science or engineering-related field.
  • Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
  • Ability to communicate effectively at all levels.
  • Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
  • Must be able to identify opportunities for optimization of processes within the department or the plant.
  • Ability to work independently or in teams.

Physical / Safety Requirements:
  • Duties may require overtime work, including nights and weekends
  • Must be able to gown for Grade C environments
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting for long hours, but may involve walking or standing for periods of time.

In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

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