Validation Specialist III

cGxPServe; Swiftwater (Monroe County); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a Validation Specialist III to enhance manufacturing processes for vaccines and biologics. This pivotal role involves ensuring compliance with cGMP regulations, leading process validation efforts, and providing technical expertise to cross-functional teams. The ideal candidate will have a strong background in biological processes, excellent communication skills, and a commitment to continuous improvement. Join a forward-thinking company dedicated to innovation and quality in the life sciences sector, where your contributions will directly impact the production of life-saving therapies.

Qualifications

• 2+ years of experience in biological processes or analytics in a cGMP environment.
• Proficiency in methodologies like Design Space and Process Control Strategies.

Responsibilities

• Develop and execute strategies for process validation in adjuvant manufacture.
• Write protocols and reports supporting manufacturing activities.

Skills

Good Engineering Practices

Quality by Design

Troubleshooting

Root Cause Analysis

Process Control Strategies

Excellent Communication Skills

Education

BS in Sciences

MS in Engineering

Pharmacy Degree

Tools

Process Performance Qualification Documents (PPQ)

PI (Process Information)

Job description

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Job Description

This position of Validation Specialist III, in the Manufacturing Science Technology and Analytics (MSAT) function of M&S-V, supports manufacturing toward industrial excellence by ensuring the accuracy, conformity, and competitiveness of processes and techniques used in the production of vaccines and biologics at industrial sites. The MSAT mission is to deliver robust and efficient processes and testing with effective know-how transfer to Manufacturing & Quality Control (QC). MTech also provides daily support to manufacturing and QC to promote industrial performance excellence.

Responsibilities

• Develop and execute strategies for development and process validation related to adjuvant manufacture. Provide input to industrialization strategies and critical process parameters. Act as Subject Matter Expert (SME) in development, validation, and investigations.
• Write protocols, reports, procedures, and memos supporting adjuvant manufacturing activities related to engineering, investigations, development, and validation runs.
• Support execution of development and validation studies and interpret results with recommendations.
• Provide technical leadership and develop training programs for relevant audiences.
• Ensure compliance with cGMP, quality, regulatory, and health and safety guidelines.
• Assess existing processes and workflows, translate processes to commercial operations, and own equipment unit operations and capabilities.
• Communicate findings and proposals to management, support non-conformance issues, and participate in Gemba walks for continuous improvement.
• Develop and update SOPs and technical documents in a cGMP environment.
• Collaborate with team members to share knowledge and foster growth.
• Lead or supervise groups in planning engineering, investigational, validation runs.
• Contribute to design space/DOE studies, establish scale-up/down parameters, and provide technical assistance for troubleshooting and process transfer.
• Support health authority inspections and site metrics achievement.
• Behave according to company values of innovation, solidarity, confidence, respect, and integrity, and work with focus, agility, accountability, and simplicity.

Requirements

• BS or MS in sciences, math, engineering, or pharmacy with 2+ years' experience in biological processes or analytics in a cGMP environment.
• Proficiency with methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies.
• Excellent communication skills, ability to work in cross-functional teams, troubleshooting, and root cause analysis skills.
• Experience with equipment start-up, qualification, validation, and proficiency with PI preferred.
• Experience in preparing and executing process performance qualification documents (PPQ) is a plus.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Research Services

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