Técnico Mecánico - Proyectos Viales

Aldesa; Oregon (WI); On-site; USD 100,000 - 140,000; Full time

Job summary

Sanofi in Swiftwater, PA seeks a Vial Filling Process Manager (2nd Shift) to oversee all shift personnel and operations, ensuring adherence to +QDCI standards and cGMPs. This role drives continuous improvement, CAPA development, and regulatory compliance for aseptic filling.

The position requires strong leadership, regulatory awareness, and a commitment to safe, high-quality vaccines production. You will coordinate production schedules, supervise teams, and communicate effectively with

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related field with relevant manufacturing/filling experience and 3+ years in pharma.
• 7+ years of experience in manufacturing/filling biological products is acceptable.
• FDA-regulated industry experience and knowledge of cGMPs are required.

Responsibilities

• Lead and schedule shift operations using manufacturing systems and tools.
• Drive continuous improvement initiatives and CAPA investigations.
• Coordinate personnel activities and review batch records for accuracy.

Skills

Leadership

Regulatory awareness

CAPA management

Data analysis

Communication

MS Office

SAP

Lean Manufacturing

Problem-solving

Education

Bachelor's degree in Life Sciences, Engineering, or a related field

Tools

SAP

Ocularis

Qualipso

eOOE

iObeya

Job description

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

• **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

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 ( ! #GD-SP #LI-SP #LI-Onsite #vhd **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 Aff