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Principal Quality Engineer
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Senior Quality Engineer
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Specialist II, Quality Engineering - Mission, United States - Sanofi-Aventis Belgium S.A.
Description
MissionVaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Facility (EVF).
The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges.
Digital will be one of the key topics to help EVF to reach its ambition.On top of it, VIA is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision:
"VIA will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+".
In this context, we are looking for a
Quality Engineering & Validation (QEV) Specialist
for our new site based in Singapore.
Key Accountabilities
The mission described below, must be exercised in compliance with health, safety, and environment of the site rules.
The QEV Specialist will be responsible to partner with cross-functional teams to provide quality oversight to commissioning, qualification, and validation (CQV) lifecycle activities ensuring compliance with Sanofi's quality requirements and the applicable regulatory expectations.
The incumbent shall be experienced in employing risk-based and science-based approach to CQV.Key accountabilities include:
Provide quality oversight of CQV lifecycle (including design, qualification, and continued verification phases) activities, including FAT/SAT, IQ/OQ/PQ, and continued verification of (but not limited to) the following:
Facilities, utilities, equipment
Temperature-controlled chambers/storage areas
Laboratory computerized equipment
Computerized system
Cleaning and disinfection
Sterilization
Manufacturing processes
Shipping/transportation
Review, evaluate, and approve CQV related non-conformities and changes, and support investigations and corrective actions.
Function as a key quality reviewer and approver of CQV lifecycle documents, including user requirements specifications, validation plans, risk assessments, engineering drawings, protocols, and reports.
Participate in system design/code reviews, ensuring the design meets the user requirements and quality standards.Support technical team in defining and establishing site's validation maintenance program to ensure that the validated state of the systems is maintained.
Liaise with CQV project team to ensure all deliverables are met on time.Ensure all qualification/validation are successfully concluded, all documentation completed, and all non-conformities are addressed, before the systems are released for GMP use.
Participate and support in regulatory inspections and site audits as quality representative.Responsible for ensuring all CQV activities meet Sanofi's quality requirements and fulfil regulatory expectations.
Partner and collaborate closely with cross functional teams to achieve site's operational readiness goals/objectives.
Education and experience
Bachelor's or Master's degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
A minimum 5-7 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
Key technical competencies and soft skills:
Sound knowledge and understanding of regulatory requirements and industry best practices (e.g., ISO, ASTM, ISPE, PDA) pertaining to management of validation lifecycle.
Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and their application to validation of systems.
Solid technical knowledgein the use and application of risk- and science-based approaches to validation.Strong interpersonal relationships to establish the partnerships necessary for the development of an engrained Quality culture.
Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
Good communication skills to present validation strategies to the site management and other functions and during inspections.Experience in greenfield/brownfield facilitystart-upswill be advantageous.
Familiar with Digital 4.0 concepts and potential applications in Quality.
Able to work independently with little supervision.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values.
We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.#J-18808-Ljbffr
