Validation Specialist III

ICON Consultants, LP; Swiftwater (Monroe County); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Validation Specialist III to join their Manufacturing Science Technology and Analytics team. This role is pivotal in ensuring compliance and efficiency in vaccine and biologic production processes. You will be responsible for protocol development, technical leadership, and continuous improvement efforts in a cGMP environment. This is an exciting opportunity to contribute to global health initiatives while working in a fast-paced, innovative setting. If you are passionate about process validation and thrive in collaborative environments, this position is perfect for you.

Qualifications

• Minimum 2+ years in biological processes within a cGMP environment.
• Experience in equipment start-up, qualification, and validation preferred.

Responsibilities

• Develop and write protocols and reports for adjuvant manufacturing.
• Ensure adherence to cGMP standards and regulatory compliance.

Skills

Analytical Skills

Communication Skills

Problem-solving

Cross-functional Teamwork

Education

BS or MS in Basic Sciences

Pharmacy

Tools

PI or similar systems

Job description

This range is provided by ICON Consultants, LP. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80.00/hr - $86.00/hr

Direct message the job poster from ICON Consultants, LP

Position Title: Validation Specialist III

Location: Swiftwater, PA

Pay Rate: $80–$86/hour

Position Overview:

We are seeking a Validation Specialist III within the Manufacturing Science Technology and Analytics (MSAT) function. This role will play a critical part in ensuring the accuracy, compliance, and competitiveness of processes and techniques used in the production of vaccines and biologics at our Swiftwater, PA industrial site. The MSAT team’s mission is to deliver robust, efficient processes and testing, along with associated know-how transfer to Manufacturing and Quality Control (QC). Additionally, the team provides daily support for Manufacturing and QC to drive industrial performance excellence.

The Validation Specialist III will contribute significantly to the strategy development and execution of development and process validation related to adjuvant manufacturing. This role will require technical leadership and expertise in multiple areas of responsibility, as well as active collaboration with cross-functional teams to drive validation and continuous improvement efforts.

Key Responsibilities:

• Protocol and Report Writing: Develop and write protocols, reports, procedures, and memos related to adjuvant manufacturing activities, including engineering, investigational, definition, development, and process validation runs.
• Study Execution and Documentation: Support and execute development and validation studies, document results, and provide technical recommendations.
• Technical Leadership: Act as a Subject Matter Expert (SME) for development, validation, and investigations, providing guidance on critical process parameters and validation strategies.
• Training Programs: Develop and execute training programs for relevant audiences, ensuring team members are up to date on the latest industry practices and regulatory requirements.
• Regulatory Compliance: Ensure adherence to cGMP standards and all internal and external quality and regulatory guidelines, including health and safety protocols.
• Process and Workflow Improvement: Assist in assessing existing processes, identifying opportunities for improvement, and translating processes to commercial operations.
• Equipment Ownership: Own and manage equipment unit operations and technology capabilities, ensuring optimal performance and alignment with quality standards.
• Continuous Improvement: Participate in Gemba/shop floor walk-throughs to gather data, identify non-conformance issues, and develop strategies for continuous process improvement.
• SOP Development: Develop and update Standard Operating Procedures (SOPs) and related technical documentation to ensure compliance and alignment with program strategies in a cGMP environment.
• Cross-functional Collaboration: Work closely with colleagues in various departments to share knowledge, promote individual growth, and drive technical contributions.

Required Qualifications:

• Education: BS or MS in basic sciences, mathematics, engineering, or pharmacy.
• Experience: Minimum of 2+ years of experience in biological processes or analytics within a cGMP environment.
• Communication Skills: Excellent written and oral communication skills, with the ability to communicate complex technical concepts to both internal and external stakeholders.
• Analytical Skills: Strong problem-solving and analytical skills for troubleshooting and root cause analysis in a cross-functional environment.
• Cross-functional Teamwork: Ability to collaborate effectively within multidisciplinary teams.
• Knowledge of Industry Standards: Familiarity with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, and Process Control Strategies.
• Equipment Start-Up and Validation: Experience in equipment start-up, qualification, and validation is preferred.
• Software Proficiency: Proficiency in PI or similar systems.
• Process Performance Qualification (PPQ): Experience in preparing and executing PPQ documentation is preferred.

Preferred Qualifications:

• Leadership Experience: Previous experience in leading or supervising teams during engineering, investigational, or process validation runs.
• Knowledge of Scale-Up/Scale-Down: Expertise in establishing scale-up/scale-down parameters and input into Design of Experiments (DOE) studies.
• Regulatory Inspections: Experience in supporting manufacturing and quality operations during health authority inspections and ensuring compliance with regulatory expectations.

About Us:

We are committed to improving global human health through the reliable, high-quality, innovative, and affordable manufacturing of vaccines and biologics. Our core values—innovation, solidarity, confidence, respect, and integrity—drive us to continually focus on agility, accountability, and simplicity in all our operations. We are looking for someone who shares our values and can thrive in a fast-paced, results-driven environment.

This role offers an exciting opportunity for a driven Validation Specialist III to work at the forefront of vaccine and biologic manufacturing. If you are passionate about process validation, regulatory compliance, and continuous improvement in a cGMP environment, we encourage you to apply.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing

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