USA-Validation Specialist III (Engineering)

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

Job summary

Join a forward-thinking company as a Validation Specialist III, where you'll play a key role in ensuring the quality and efficiency of vaccine production processes. This position involves writing protocols, supporting validation studies, and providing technical leadership in a collaborative environment. You will work closely with manufacturing and quality control teams to improve processes and ensure compliance with industry standards. If you are passionate about contributing to human health and thrive in a dynamic setting, this opportunity is perfect for you to make a significant impact.

Qualifications

• 2+ years of experience in a cGMP environment focusing on biological processes.
• Proficient in structured methodologies like Quality by Design and Process Control Strategies.

Responsibilities

• Write protocols and reports to support manufacturing activities.
• Provide technical leadership and assist in process troubleshooting and improvement.
• Develop and execute training programs for appropriate audiences.

Skills

Analytical Skills

Written Communication

Oral Communication

Problem Solving

Collaboration

Education

BS or MS in Basic Sciences

Experience in Biological Processes

Tools

Process Performance Qualification (PPQ)

PI

Job description

Job Title: Validation Specialist III

Location: Swiftwater, PA

Duration: 8+ months

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 the vaccines and biologics manufactured at the Sanofi industrial sites. The mission of MSAT is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech's function also provides daily support, for manufacturing and QC, toward industrial performance excellence.

Accountabilities:

1. Write protocols, reports, procedures, and memos as needed to support adjuvant manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs.
2. Support execution of development and validation related studies.
3. Document and interpret study results with recommendations.
4. Provide technical leadership as a subject matter expert in multiple areas of responsibility.
5. Develop and execute training programs for appropriate audiences.
6. Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
7. Assist with assessing existing processes and workflows.
8. Translate processes to commercial operations.
9. Ownership of equipment unit operations and technology capabilities.
10. Communicate findings and proposals to upper management.
11. Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
12. Participate in Gemba/shop floor walk through to learn about production processes and/or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
13. Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
14. Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.

The Job Responsibilities Include:

1. Write protocols, reports, procedures and memos as needed to support Adjuvant manufacturing activities related to engineering, investigational, definition, development and process validation runs.
2. Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
3. Input to design space/DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals (mixing, mass/heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
4. Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI).
5. Behave according to company values and competencies.
6. Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
7. Effectively communicate successes, constraints, conflicts, solutions and actions for resolution.
8. Proactively resolve conflicts, remove roadblocks to execution within sphere of influence; escalate to functional management when appropriate.
9. Foster relationships with partners and customers in order to achieve technical objectives.

Who You Are

Sanofi's M&S-V mission is to improve worldwide human health, as a reliable manufacturer, by delivering high quality, innovative, and affordable products to our customers. You would fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).

Education and experience

Basic Qualifications:

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

Preferred Skills:

1. Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
2. Excellent written and oral communication skills.
3. Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
4. Experience in equipment start-up, qualification and validation is preferred.
5. Proficiency with PI.
6. Prior experience preparing and executing process performance qualification documents (PPQ) preferred.

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