Vial Filling Process Manager (2nd Shift)

Job Title: Vial Process Manager

Location: Swiftwater, PA

About the Job

The Vial Process Manager is responsible for overseeing all personnel and operational activities within their assigned shift, ensuring full team adherence to +QDCI standards. This role drives continuous improvement of line performance by leading and supporting strategic projects and initiatives, including thorough investigation of deviations from planned outcomes and the development of robust Corrective and Preventive Actions (CAPA) to prevent recurrence. The position requires strong leadership, people managing skills, shift flexibility for coverage and project completion, regulatory awareness, and a commitment to producing safe, high-quality aseptic products.

This role manages all shift-level processes to meet departmental goals and priorities while ensuring full compliance with regulatory authorities including cGMPs, CBER, WHO, EP, and other applicable regulatory bodies.

Key responsibilities include planning and initiating production schedules, coordinating personnel activities across manufacturing teams, and reviewing batch records for accuracy and completeness. The role carries broad accountability across employee development, counseling, cost reduction recommendations, quality assurance, incident investigations, CAPAs, and departmental budget management. Shift flexibility is required to drive project completion.

The position serves as the primary managerial coverage for shift employees and acts as a key liaison for communicating technical issues and process improvements to relevant stakeholders (e.g., IOC, Management Committee, staff meetings). When required, this role coordinates Maintenance, Metrology, and Validation activities with functional leaders and plays an active role in implementing new equipment and procedures.

Deviation management, people development, and Quality Assurance of the Aseptic Processing area are core to this role. A background in Aseptic Processing is strongly preferred.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale - and shape the future of immunization.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

Main Responsibilities

 Production Management, Lead and schedule shift operations using eOOE, iObeya, Qualipso, SAP, and Ocularis

 Critical Function Leadership, Execute 5W2H analyses, Gembas, MSVs, LSVs, real-time reviews, BFRs, and audits

Process Improvement & Projects, Identify and lead continuous improvement initiatives that enhance performance and reduce waste

Cross-Functional Coordination, Partner with departments to align priorities and achieve +QDCI standards

 PCU Development & Training, Support team growth through coaching and training

Personal Development, Pursue professional growth through assigned training and certifications

Key Accountabilities

Safety: Enforce safety procedures, conduct LSVs/MSVs, report incidents, participate in walkthroughs and investigations

Quality: Ensure cGMP compliance, lead 5W2H/deviation meetings, develop CAPA, conduct real-time reviews, maintain Quality relationships

Delivery: Analyze data to drive performance improvements, support production flexibility, follow escalation procedures, review eOOE metrics, ensure timely training

Cost: Drive CI and cost reduction initiatives, minimize deviations, improve operator efficiency, support changeover functions

Involvement: Complete training modules, maintain qualified trainer status, train new team members, lead meetings professionally

Physical Working Conditions

Office environment and proper PPE >50% of time; isopropyl alcohol exposure

About You

Education

Bachelor's degree in Life Sciences, Engineering, or a related field with relevant manufacturing/filling experience and 3+ years of experience in manufacturing and/or development within a pharmaceutical environment

OR 7+ years of relevant experience in manufacturing and/or filling of biological products

Experience

3+ years of experience in manufacturing and/or development within a pharmaceutical environment

Prior experience in an FDA-regulated industry is required

Working knowledge of cGMPs is required

Experience with aseptic processing is strongly preferred

Skills & Competencies

Highly detail-oriented and organized with strong time-management capabilities

Strong analytical and problem-solving skills with the ability to adapt in a dynamic environment

Excellent verbal and written communication, interpersonal, and presentation skills

Ability to interact effectively with employees at all levels of the organization

Intermediate proficiency in MS Office Suite

Working knowledge of SAP (preferred)

Familiarity with Lean Manufacturing principles (preferred)

Mechanical and engineering competency (preferred)

Engineering background (preferred)

Key Competencies

Operational Excellence

Drives consistent, high-quality production outcomes through disciplined planning and execution.

Technical Expertise

Applies deep knowledge of aseptic manufacturing to solve complex process challenges

People Leadership

Inspires, develops, and empowers teams to achieve their full potential

Regulatory Acumen

Ensures full compliance with applicable regulations and internal quality standards

Continuous Improvement

Proactively identifies opportunities to improve processes, systems, and outcomes

Cross-Functional Collaboration

Builds strong partnerships across departments to achieve shared goals

Data-Driven Decision Making

Leverages production data and digital tools to inform priorities and actions

Patient Safety Focus

Maintains an unwavering commitment to product quality and patient safety in all decisions

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.

Pursue Progress . Discover Extraordinary .

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color , ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch ‘One day at Sanofi’ and check out our Culture, Inclusion and Experience initiatives at sanofi.com !

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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$78.000,00 - $112.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .