Quality Continuous Improvement

Job title: Quality Continuous Improvement

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Provides leadership and technical engineering expertise for quality processes, procedures, troubleshooting, investigations, improvement projects, capas and change controls.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Leads continuous improvement (CI) projects to identify the sources of manufacturing process variability, design and implement engineering solutions to improve.

• Leads / supports technical investigations into production defects including the resulting design and implementation of engineering solutions.

• Leads Failure Mode and Effects Analysis (FMEA) assessments on new biotech manufacturing systems and supports designing appropriate controls.

• Collaborates with the Engineering Dept on engineering and automation controls and testing associated with new equipment and facilities.

• Collaborates with Manufacturing Science and Analytical Technology (MSAT) on technical projects associated with process development and validation.

• Provides quality engineering input into engineering designs for new equipment and processes.

• Leads / supports quality continuous improvement projects to improve process reliability and reduce cost. 20%

• Leads / supports pro-active risk management processes such as FMEA to identify areas of potential failure and design / implement system controls as needed. 20%

• Leads / supports technical quality investigations driven by quality events. 20%

• Provides Quality input and oversight into design, testing and validation activities carried out by the Engineering and MSAT departments. 20%

• Collaborates within site(s) and across the sanofi network as required on Quality Engineering topics.  20%

Scope and dimensions

• Breadth of responsibility (global/regional/country/site):  Swiftwater and Protein Sciences Sites

• Key dimensions:   Project PKMs, KPIs, Cost, Defects

• Key performance indicators:  process reliability, PPKs, defect rates, Quality metrics, cost reduction

• Interact successfully within the highly energized production and regulatory environments.

• Freedom to act, level of autonomy: high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements

• Headcount management:  No direct reports

About You

Education and experience

• A minimum bachelor’s degree in Engineering or related field with 1-4 years of cGMP experience.

• Basic understanding of biotech / vaccine manufacturing processes

• Basic understanding of quality principles such as Quality by Design

Competencies –

• the jobholder will be evaluated on 4 key competencies: Act for Change, Strive for Results, Communicate Transversally, Commit to Customers.

Key Technical Competencies and Soft Skills:

• Basic understanding of cGMPs