USA-Validation Specialist III (Engineering)

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

Job summary

An innovative firm is seeking a Validation Specialist III to enhance manufacturing excellence in vaccine production. This role involves developing and executing validation strategies, ensuring compliance with cGMP standards, and providing technical leadership across cross-functional teams. You will be pivotal in writing protocols, documenting study results, and facilitating training programs. Join a mission-driven organization that values integrity, innovation, and collaboration, and contribute to improving global health through high-quality products.

Qualifications

• 2+ years of experience in biological processes or analytics in a cGMP environment.
• Proficiency in structured methodologies for industrial process design.

Responsibilities

• Write protocols and reports for adjuvant manufacturing activities.
• Support and lead execution of engineering, development, and validation studies.
• Communicate findings and proposals to upper management.

Skills

Biological Processes

Analytical Skills

Good Engineering Practices

Quality by Design

Root Cause Analysis

Communication Skills

Education

BS or MS in Sciences

Pharmacy

Tools

PI Systems

Job description

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

• Key contributor to strategy development and execution of development and process validation related to adjuvant manufacture. Provides input to industrialization strategies and critical process parameters. Acts as Subject Matter Expert (SME) for development, validation, and investigations. Collaborates with cross-functional teams across M&S-V to deliver:

Accountabilities:
• Write protocols, reports, procedures, and memos to support adjuvant manufacturing activities related to engineering, investigations, definition, development, and process validation runs.
• Support execution of development and validation studies.
• Document and interpret study results with recommendations.
• Provide technical leadership as a SME in multiple responsibility areas.
• Develop and deliver training programs for relevant audiences.
• Ensure compliance with cGMP, internal and external quality, regulatory, and health and safety guidelines.
• Assist in assessing existing processes and workflows.
• Translate processes for commercial operations.
• Own equipment unit operations and technology capabilities.
• Communicate findings and proposals to upper management.
• Support non-conformance issues, change controls, deviations, CAPAs to improve Manufacturing Technology programs.
• Participate in Gemba/shop floor walks and stakeholder interviews for continuous improvement and validation strategy development.
• Develop and update SOPs and technical documents aligned with program strategies under cGMP.
• Collaborate with department members to share knowledge and foster growth.

The Job Responsibilities Include:
• Write protocols, reports, procedures, and memos for adjuvant manufacturing activities.
• Support and lead execution of engineering, development, and validation studies.
• Contribute to design space / DOE studies, establishing scale-up/down parameters using engineering fundamentals.
• Provide technical support for troubleshooting, process improvement, tech transfer, and inspections.
• Demonstrate company values and competencies.
• Promote collaboration, efficiency, and continuous improvement.
• Communicate effectively about successes, constraints, and solutions.
• Resolve conflicts proactively and escalate issues as needed.
• Build strong relationships with partners and customers to meet technical objectives.

Who You Are
MSAT’s mission is to improve global human health by providing high-quality, innovative, and affordable products. You would align with our values of innovation, solidarity, confidence, respect, and integrity, and our working principles of Focus, Agility, Accountability, and Simplicity.

Education and experience
Basic Qualifications:
BS or MS in sciences, math, engineering, or pharmacy with 2+ years’ experience in biological processes or analytics within a cGMP environment.

Preferred Skills:
• Proficiency in structured methodologies like Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies for industrial process design, validation, and control.
• Strong written and oral communication skills.
• Ability to work in cross-functional teams, troubleshoot, and perform root cause analysis.
• Experience with equipment start-up, qualification, validation, and process performance qualification documents preferred.
• Proficiency with PI systems.
• Prior experience with PPQ documents preferred.

EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate based on Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”