USA-Validation Specialist III (Engineering)

HireTalent; Swiftwater (Monroe County); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Validation Specialist III to support the manufacturing of vaccines and biologics. This role involves developing and executing validation strategies, ensuring compliance with regulatory standards, and providing technical leadership in a cGMP environment. The ideal candidate will have a strong background in biological processes, excellent communication skills, and a passion for innovation. Join a team dedicated to improving human health through high-quality products and be part of a collaborative environment that fosters growth and continuous improvement.

Qualifications

• 2+ years’ experience in biological processes or analytics in a cGMP environment.
• Proficiency with Good Engineering Practices and Quality by Design methodologies.

Responsibilities

• Developing strategies related to development and process validation for adjuvant manufacture.
• Writing protocols, reports, and procedures to support manufacturing activities.
• Ensuring compliance with cGMP and regulatory guidelines.

Skills

Biological processes

Analytical skills

Troubleshooting

Root cause analysis

Communication skills

Education

BS or MS in sciences, math, engineering, or pharmacy

Tools

Good Engineering Practices

Quality by Design

Design Space

Process Control Strategies

PI

Job description

The Position
This position of Validation Specialist III, in the Manufacturing Science Technology and Analytics (MSAT) function of M&S-V, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity, and competitiveness of the processes and techniques utilized for the production of vaccines and biologics at the *** industrial sites. The mission of MSAT is to deliver robust and efficient processes & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech’s function also provides daily support for manufacturing and QC to achieve industrial performance excellence.

Key responsibilities include:

1. Developing and executing strategies related to development and process validation for adjuvant manufacture, including providing input to industrialization strategies and identifying critical process parameters.
2. Serving as Subject Matter Expert (SME) for development, validation, and investigations.
3. Writing protocols, reports, procedures, and memos to support adjuvant manufacturing activities.
4. Supporting the execution of development and validation studies, documenting and interpreting results with recommendations.
5. Providing technical leadership and developing training programs.
6. Ensuring compliance with cGMP, quality, regulatory, and safety guidelines.
7. Assessing existing processes and workflows, translating processes to commercial operations, and owning equipment and technology capabilities.
8. Communicating findings and proposals to management, supporting non-conformance issues, and participating in Gemba walks for continuous improvement.
9. Developing and updating SOPs and technical documents in a cGMP environment.
10. Collaborating with team members to share knowledge and encourage growth.

Job Responsibilities:

• Supporting engineering, investigational, definition, development, and process validation runs.
• Leading or supervising groups in planning validation activities.
• Contributing to design space / DOE studies, including establishing scale-up/scale-down parameters.
• Providing technical assistance for troubleshooting, process improvement, and technical transfer.
• Behaving according to company values and fostering collaboration and continuous improvement.
• Effective communication and conflict resolution.
• Building relationships with partners and customers to achieve objectives.

Who You Are

Aligned with ***’s mission to improve human health through high-quality, innovative, and affordable products, you embody our values of innovation, solidarity, confidence, respect, and integrity, and adhere to our ways of working: Focus, Agility, Accountability, and Simplicity.

Education and Experience:

• BS or MS in sciences, math, engineering, or pharmacy, with 2+ years’ experience in biological processes or analytics in a cGMP environment.

Preferred Skills:

• Proficiency with methodologies like 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.
• Experience with equipment start-up, qualification, validation, and proficiency with PI.
• Experience in preparing and executing PPQ documents is preferred.