Vial Filling Process Manager (2nd Shift)

BioSpace; Swiftwater (Monroe County); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

High-quality healthcare

Prevention and wellness programs

14 weeks parental leave

Job summary

Sanofi is seeking a Vial Process Manager in Swiftwater, PA to oversee shift operations, drive continuous improvement, and ensure strict adherence to cGMP and regulatory standards. The role requires strong leadership, project management, and capability to coordinate across manufacturing teams to meet quality and safety goals.

You will lead deviations investigations, CAPA development, and routine reviews, while fostering a culture of safety and continuous improvement in aseptic processing

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field with pharma manufacturing experience.
• 3+ years in pharmaceutical manufacturing and/or development.
• 7+ years in manufacturing/filling of biological products.

Responsibilities

• Lead shift production management and schedule operations under GMP-compliant systems (eOOE, iObeya, Qualipso, SAP, Ocularis).
• Perform 5W2H analyses, audits, real-time reviews, and CAPA investigations.
• Identify and drive continuous improvement to enhance performance and reduce waste.
• Coordinate cross-functional teams to align priorities with +QDCI standards.
• Develop PCU and provide coaching and training to team members.
• Support professional growth through training and certifications.

Skills

Detail-oriented

Time management

Analytical skills

Communication

Interpersonal skills

MS Office proficiency

SAP knowledge

Lean Manufacturing

Engineering background

Education

Bachelor's degree in Life Sciences/Engineering

7+ years experience in manufacturing/filling of biological products

Tools

eOOE

iObeya

Qualipso

SAP

Ocularis

Job description

About The Job

Job Title: Vial Process Manager

Location: Swiftwater, PA

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 peoples 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 peoples lives.

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 <15%; lifting up to 25 lbs as needed

About You

Education

• Bachelor's degreein 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
• OR7+ 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 industryis required
• Working knowledge of cGMPsis 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 its 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 doesnt 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. Lets pursue progress. And lets 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!

#GD-SP

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.