Quality Assurance Validation Engineer

Sanofi•Waltham, MA

3d•Onsite

About The Position

The QAV Engineer will support both the Business System Owners and cross-functional technical departments (Validation, Metrology and Automation) at Sanofi’s mRNA Center of Excellent (CoE) and will report to the Deputy Director, Quality Assurance Validation. This individual will be responsible for supporting all field activities supporting internal and external QA Validation efforts as it pertains to Sanofi‘s mRNA Center of Excellence - at its various internal facilities and CMO’s. This individual will be responsible for supporting a team of FTE’s and consultants for Validation and Computer Systems Validation efforts at or on behalf of Sanofi’s mRNA CoE, for QAV related activities.

Requirements

Bachelor’s degree in mechanical engineering, chemical engineering, computer science, or related fields relevant to the biotech or pharmaceutical industry.
Minimum 3+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries.
Minimum 3+ years of experience working with facility startups, factory/site acceptance testing, Commissioning/Qualification activities and all associated supporting documentation generated during the course of these activities.
Experience with continuous improvement of Validation operations in response to business needs and customer audits/regulatory inspections.
Experience in execution of field activities associated with validation protocols, project plans, data analysis, compilation of data into final reports and project summary/close out.
Experience in asset management and in NIST traceability to standards.
Demonstrated experience in working in compliance with US, EU and ICH GMP requirements.
Excellent oral and written communication skills.
Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts.

Nice To Haves

Preferable experience in early phase clinical efforts, which are not under the stringent requirements of a commercial facility.
Preferable experience in supporting a Phase I/II company up through commercialization.

Responsibilities

Support and work in partnership with Validation, Automation, Metrology and Quality Control department personnel as well as cross-functionally with sub-QA departments to achieve deliverable and all routine Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment and build strong working relationships.
Provide QA oversight for GMP validation activities and apply risk-based methodology to validation efforts to help drive deliverables on time in a compliant manner, while serving as the QA Validation Subject Matter Expert and interacting with Business System Owners on their needs.
QAV support on the necessary Project Plans, end to end Validation deliverables and supports any field activities performed in support of their execution.
Help enforce compliance with senior leadership strategy and direction, as it pertains to the areas of equipment validation, computer systems validation, cleaning validation, Data Integrity initiatives and routine maintenance of validated systems.
Help author and maintain Standard Operating Procedures incompliant with internal/global standards to support Equipment and Computer System validation for GMP.
Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs.
Provide QA assessment and approval of GMP validated systems related procedures, deviations, CAPAs and change controls with no supervision depending on complexity of system.
Provide support for additional QAV-related activities during internal audits and self-inspections, supporting documentation, investigations and remediation activities as required.
Act as the QA contact and QA subject matter expert (SME) on the Metrology and Automation of all equipment/instruments partnering with technical departments and Business System Owners to ensure Data Integrity and cGMP compliance.
Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs.
Help investigate and support management in all investigations stemming from Equipment/System failure and determines best course of action for resolution.
Promote a Quality Culture Support innovation, teamwork and a continuous improvement effort in the level of Quality in Sanofi’s mRNA CoE documentation.
Ensure that Sanofi’s mRNA CoE Validation documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
Implementing the process and tool at local level in line with the standardized and harmonized approach, including communication, change management, etc as appropriate.
Being the "Voice of Customer"
Providing feedback on the roadblocks and difficulties met related to Sanofi Community of Practice (CoP) area supported
Providing return on experience on inspection assessing the CoP area supported
Proposing evolution for simplification and harmonization of the process and tool
Sharing successes and best practices with other sites
Contributing to the objectives set via the CoP roadmap