Senior Validation Specialist

Job Description:

Pay Range: $80.26hr - $83.26hr

Accountabilities:

• 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
• Support execution of development and validation related studies.
• Document and interpret study results with recommendations
• Provide technical leadership as an subject matter expert in multiple areas of responsibility
• Develop and execution of training programs for appropriate audiences
• Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
• ssist with assessing existing processes and workflows.
• Translate processes to commercial operations.
• Ownership of equipment unit operations and technology capabilities.
• Communicates findings and proposals to upper management.
• Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
• 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.
• Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
• Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributors.

The Job Responsibilities:

• Write protocols, reports, procedures and memos as needed to support Adjuvant manufacturing activities related to engineering, investigational, definition, development and process validation runs
• 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.
• 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.
• Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer and health authority inspections to achieve site metrics (+QDCI).
• Behaves according to company values and competencies.
• Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
• Effectively communicates successes, constraints, conflicts, solutions and actions for resolution.
• Proactively resolves conflicts, removes roadblocks to execution within the sphere of influence; escalates to functional management when appropriate.
• Fosters relationships with partners and customers in order to achieve technical objectives.
• 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.
• Candidates would fit in well with our 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:

• 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.
• Excellent written and oral communication skills.
• bility to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
• Experience in equipment start-up, qualification and validation is preferred.
• Proficiency with PI.
• Prior experience preparing and executing process performance qualification documents (PPQ) preferred.