Description:

This position is responsible for providing expertise, quality oversight and guidance with regards to regulatory requirements and best practices related to manufacturing process equipment qualification including computerized systems validation.

The candidate will participate in project workstreams, ensure proper execution of validation strategies as well as providing support for the quality processes and procedures. This individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS.

Responsibilities:

• Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management.
• Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.
• Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.
• As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.
• Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.
• Bachelor’s Degree in Engineering / Science or related field
• 4+ years of experience in a GMP controlled environment/pharmaceutical industry is required

Experience:

• Experience with qualification of manufacturing process equipment is required (examples of manufacturing equipment include: Isolators, Fermentors, Microfiltration and Ultrafiltration systems, Centrifuges, Microplate Readers, etc.)
• Experience with computerized systems validation is required
• Experience with qualification of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset
• Technical writing, effective oral and written communication skills, and strong compliance mindset.
• Good understanding of current and evolving regulatory requirements

Competencies:

• Strong communication, interpersonal skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS. Good interpersonal and influencing skills are important for a candidate’s success in this role.

Planning and organizational skills:

• Ability to anticipate evolutions due to internal and external factors.
• Conflict resolution and problem solving.
• Familiarity with strategic planning, balanced judgment and risk analysis.