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Pharmaceutical Validation Manager Jobs (NOW HIRING)

PCI Pharma Services

VALIDATION ENGINEER IV

Bedford, NH · On-site

... cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer provides guidance to internal project teams and ...

PCI Pharma Services

VALIDATION ENGINEER IV

Bedford, NH · On-site

... cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer provides guidance to internal project teams and ...

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Pharmaceutical Validation Manager information

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$47.5K

$105.4K

$160.5K

How much do pharmaceutical validation manager jobs pay per year?

As of Jul 3, 2026, the average yearly pay for pharmaceutical validation manager in the United States is $105,415.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $132,000.00 per year, depending on experience, location, and employer.

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

To thrive as a Pharmaceutical Validation Manager, you need a solid background in pharmaceutical sciences, engineering, or a related field, often supported by a relevant degree and experience in GMP-regulated environments. Familiarity with validation lifecycle documentation, risk assessment tools, and regulatory software systems such as TrackWise or Veeva Vault is typically required. Strong leadership, problem-solving, and communication skills set outstanding managers apart, enabling them to lead cross-functional teams and ensure compliance. These skills and qualities are crucial for maintaining product quality, meeting regulatory standards, and ensuring the safe and efficient production of pharmaceuticals.

What does a Pharmaceutical Validation Manager do?

A Pharmaceutical Validation Manager oversees the validation processes for equipment, systems, and processes within pharmaceutical manufacturing to ensure compliance with regulatory standards such as FDA and EMA guidelines. Their responsibilities include planning, coordinating, and documenting validation activities, managing teams, and ensuring that products meet quality and safety requirements. They play a key role in ensuring that all manufacturing procedures consistently produce products that meet predetermined quality criteria. Additionally, they may liaise with regulatory agencies during inspections and audits.

What are some common challenges faced by Pharmaceutical Validation Managers during regulatory inspections?

Pharmaceutical Validation Managers often encounter challenges during regulatory inspections, such as ensuring all validation documentation is complete, up-to-date, and compliant with current Good Manufacturing Practices (cGMP). Another challenge is demonstrating that all equipment and processes consistently operate within specified parameters, especially when inspectors request traceability and data integrity. Being able to quickly and accurately address auditor questions, provide supporting evidence, and manage unexpected findings requires thorough preparation and strong organizational skills.
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Pharmaceutical Validation Manager jobs near you
Infographic showing various Pharmaceutical Validation Manager job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 90% Physical, 2% Hybrid, and 8% Remote job distribution, with an average salary of $105,415 per year, or $50.7 per hour.
Product Process Validation Manager

Product Process Validation Manager

kindeva

Bridgeton, MO

Other

Posted 2 days ago

Kindeva rating

6.8

Company rating: 6.8 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.

Role Responsibilities

Process Validation & PPQ

  • Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11).
  • Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
  • Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance.
  • Ensure validation deliverables meet internal standards and external regulatory requirements.

Technology Transfer

  • Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing.
  • Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation.
  • Drive process fit-gap assessments, risk analyses, and mitigation strategies.
  • Support equipment and facility readiness, including URS development and process capability assessments.

Continued Process Verification (CPV)

  • Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making.
  • Lead investigations and corrective actions related to process performance deviations or CPV signals.

Cross-Functional Leadership

  • Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes.
  • Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections.
  • Provide technical leadership during audits and regulatory inspections.
  • Mentor and guide junior MS&T staff in validation and tech transfer best practices.

Documentation & Compliance

  • Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready.
  • Maintain strong alignment with internal quality systems, change control, and document management processes.
  • Champion continuous improvement initiatives to enhance validation efficiency and process robustness.

Basic Qualifications

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
  • 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical functions.
  • Demonstrated expertise in PPQ, CPV, and technology transfer.
  • Strong understanding of cGMP regulations and global validation guidelines.
  • Excellent technical writing, communication, and project management skills.

Preferred

  • Experience with biologics, cell therapy, gene therapy, or aseptic manufacturing.
  • Familiarity with statistical tools (e.g., JMP, Minitab) for process analysis.
  • Prior leadership or team management experience.
  • Experience supporting regulatory inspections.

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