Vial Filling Process Owner Manager
Swiftwater, Pennsylvanie Permanent Posté le Aug. 27, 2025Job Title: Vial Filling Process Owner Manager
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.
This is a 3rd shift position.
Manages process within a product team to meet goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Plans and initiates the overall production schedules and coordinates personnel activities with other manufacturing staff. Reviews batch records for correctness and completeness.
Overall responsibilities include recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets. Also responsible for Quality Systems including deviation investigation and CAPA/Change Control implementation.
Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, Management Committee, staff meetings), and work unit teams. When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders. Takes a role in implementing new equipment and procedures. Performs all other duties as required by department management. Deviation management, people development, and Quality Assurance of the Aseptic Processing area are required. Background in Aseptic Processing is favorable.
This role is for an exempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.
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:
Their responsibilities are, but are not limited to:
Safety:
Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings
Reports all safety issues, concerns, incidents and near misses to the team leadership
Actively participates in safety walkthroughs coordinated by the department’s safety team
Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions
Follows effective procedures to ensure the production of a safe and efficacious product.
Utilizes +QDCI boards for Safety issues
Quality:
Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections
Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies
Supports SGS meetings and proactively addresses observations
Conducts real time reviews to assess aseptic performance, GMP data entries, and all metrics are accurately updated
Understands the function of the quality group and works with them to maintain a positive rapport.
Delivery:
Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.
Follows escalation procedures to mitigate any variables negatively impacting eOOE.
Reviews eOOE metrics throughout shift to ensure proper categorization of downtime.
Ensure training of personnel is assigned and entered as needed in order to support business needs.
All other duties as assigned. Adheres to all other company time keeping and attendance policies.
Cost:
Executes procedure as documented to avoid deviations.
Ensure training methodologies are implemented to improve operator efficiencies.
Supports all changeover related functions to achieve eOOE standard.
Involvement:
Works to become trained in all assigned training modules.
Trains and orients new team members (at any level) as assigned.
Participates and leads team meetings. Understands respect, professionalism and confidentiality.
Ensures Training coordinator / Trainers, train and guide personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques, and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.
All other duties as assigned.
About You
Education/experience
Must be very detail-oriented and organized with excellent time-management skills
Strong analytic and problem-solving abilities, as well as the flexibility to change and adapt as the job grows and develops
Strong data analysis skills.
Excellent verbal and written communication, interpersonal and presentation skills, as well as the ability to interact tactfully and effectively with employees at all levels of the organizational structure
Intermediate proficiency in MS Office Suite
Working knowledge of SAP preferred
Lean manufacturing preferred
Education:
BS degree in Life Sciences or Engineering with 3-5 years relevant experience in manufacturing and/or filling of biological products
7+ years relevant experience in manufacturing and/or filling of biological products in lieu of degree
Experience Required:
Must have previous experience in working with a production department of a pharmaceutical company.
Experience in FDA Regulated Industry
Working knowledge of cGMP's
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to gain experience 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 diligent 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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; 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.
#GD-SP
#LI-SP
#LI-Onsite
#vhd
Toujours Progresser. Découvrir l’Extraordinaire.
Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.
Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.
Vous n'avez pas encore consulté aucune d'offres d'emploi
Vous n'avez pas encore enregistré d'offres d'emploi.
Carrières Sanofi aux USA
Rejoignez notre équipe américaine pour profiter d’un mentorat d’experts et de plateformes de formation, en accord avec notre culture. Votre passion et votre énergie seront mises à profit pour créer des vaccins et des médicaments qui réduisent de moitié le délai entre la découverte et la thérapie.
En savoir plus
sur ce site
Un monde de possibilités
-
-
-
Pourquoi Sanofi ?
Accédez aux outils, à la formation et au soutien nécessaires pour atteindre vos objectifs. En réalisant votre plein potentiel, vous nous aiderez à atteindre notre objectif de réduire de moitié le temps entre la découverte et la thérapie.
-
Quand vous évoluez, nous évoluons avec vous
Nous nous engageons à vous soutenir à travers une politique de rémunération complète, soigneusement élaborée pour contribuer à votre bien-être physique, financier, mental et social. Peu importe votre rôle, vous vous épanouirez au sein de nos équipes inclusives.
-
Nos sites
Nous sommes présents dans plus de 60 pays, tous unis pour définir l'avenir de la santé. Votre carrière évoluera aux côtés d'experts et grâce à la technologie au service des plus grandes avancées.
-
Notre culture et nos valeurs
Premiers en pharma avec un comité DE&I, nous valorisons chaque voix. Avec Sanofi, faites entendre la vôtre pour bâtir notre avenir.
-
Construisez une carrière qui a du sens
Exprimez votre passion et impactez des millions de personnes à travers le monde. Vous êtes aux commandes : fixez vos objectifs et nous vous offrirons la formation et le soutien nécessaires pour les atteindre.
-
Lancez votre carrière
Explorez les possibilités : apprentissage, stages, postes pour jeunes diplômés, mobilité internationale. Vous serez accompagné pour avoir un impact significatif.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
-
-
-
Meet Robin, Digital Product Owner, Belgium
Dive into the digital world with Robin Meuris, as he discusses his role as a Digital Product Owner in Belgium.
-
Meet Nils Libert, Associate Scientist in R&D
Meet Nils Libert, an Associate Scientist contributing to groundbreaking research in R&D, Belgium.
-
Meet Stefanie Van Poucke, GMP QA Head
Join Stefanie Van Poucke as she navigates the world of Quality Assurance, leading GMP QA efforts in R&D, Belgium.
-
Meet Ádám Honvéd, Product Owner Process Analytics
Step into the world of analytics with Ádám Honvéd as he shares his journey as a Product Owner for Process Analytics at our Budapest Hub.
-
Meet Azer Hallabi, Project Manager, Global Regulatory Affairs
Discover the dynamic world of regulatory affairs with Azer Hallabi, Project Manager in Global Regulatory Affairs at our Budapest Hub.
-
Meet Orsolya Dina, Receivables & Revenue Team Lead
Follow Orsolya Dina’s inspiring journey as she embraces new opportunities for growth and advancement.
-
Julien Guyomard: From Cars to COVID to Canada
How seizing opportunities built a global career. Julien's career in communications has taken him from the production lines of French car factories to the global stage of the Paris 2024 Olympics and finally to leading communications in Canada.
-
Dachuan Li: From Operating Room to Medical Education
Dachuan Li traded his surgical scrubs for a career bridging science and healthcare as a Medical Science Liaison (MSL) in China.
-
Vincent Dufauret: Embracing the Unexpected - Building a Versatile Career
Currently Global Digital Communication Project Lead, Vincent reflects on his diverse career journey. He shares the insights he wishes he'd understood from the beginning.
-
Carmen's Sanofi Journey: A Son’s Rare Diagnosis, a Renewed Mission
Carmen María Escamilla is Head of Customer Care in Supply Chain, based in Mexico. She discusses how personal experience with her son's rare genetic disorder helped shape her 11-year pharmaceutical career journey and why ensuring medicine availability has become her mission.
-
Balancing Career and Family: How Sanofi's Employee-First Culture Creates Opportunity in China
Lewis Lai, Direct to Patient (DTP) & Dual channel Pharmacy (DCP) Channel Manager based in Hangzhou, China, shares how Sanofi's supportive workplace policies and culture have enabled him to thrive professionally while embracing fatherhood.
-
One Sanofi Career, Many Chapters: Bold Moves and Saying ‘Yes’ Drives Growth
Istanbul-based Şayan Tomris Örs, currently Polio, Pertussis, and Hib (PPH) Head of Eurasia for Vaccines at Sanofi, discusses her journey from chemical engineering graduate to marking leader to head up a franchise.
-
Sustainability at the Heart: How Sanofi's Transformation is Building a Purpose-Driven Culture
Serena Ceccarelli reveals how Sanofi's integrated approach to sustainability is transforming the pharmaceutical giant while creating lasting social value through ambitious environmental targets and expanded healthcare access.
-
Finding Purpose at Sanofi: A Finance Professional's Path to Making a D
Hungarian Senior Financial Analyst Zoltán Borbás shares how the Budapest Hub offers a springboard for career growth while working for a company with real-world impact.
-
Team Science: Building Breakthroughs Across Borders and Disciplines
Frankfurt-based Dr. Nadine Biesemann, Distinguished Scientist and Section Head for Immunology Research at Sanofi, reflects on how collaborative approaches and diverse perspectives accelerate medical innovation.
-
Lab Bench to Global Strategy: How Scientific Passion Led to Immunology Leadership
Aayam Lamichhane, Head of Strategy and Operations for Sanofi's Global Immunology Franchise, shares how his childhood fascination with science, a commitment to serving patients, and a drive to create meaningful change in the world led to a remarkable career journey across continents.
-
-
-
-
Meet Matthew Odogwu, Associate Brand Manager Flu & Travel, UK & Ireland
Matthew is one of Sanofi’s Emerging Talent Graduate Scheme participants. Through hands-on rotations across different business units, he’s developed a diverse skill set – from tender management to marketing – while gaining real ownership and accountability.
-
Meet Douglas Penson, Sustainability Apprentice, UK & Ireland
Douglas is a Corporate Responsibility and Sustainability Apprentice with a passion for the environment. Through his apprenticeship at Sanofi, Douglas is gaining valuable knowledge and contributing to meaningful, purpose-driven work.
-
-
How Motherhood Accelerated My Career at Sanofi
Bangkok-based Wipada Kitiratanatrakarn, Brand Lead for Polio, Pertussis, and Hib Vaccines across Southeast Asia and India at Sanofi, reveals how becoming a mother transformed her approach to leadership and opened doors she never thought possible.
-
Finding The Role I Was Meant For
Le Thanh Man, Customer Engagement Manager for Sanofi Vaccines in Vietnam, reveals how early rejection became the catalyst for a decade of intentional growth, and how Sanofi's career development resources helped him build the career he'd always envisioned.
-
Making an Impact Beyond the Office
From disaster relief in California to mentoring young scientists and joining the global stage at the Paris Olympics, each experience can deepen your sense of purpose – and help your career take root and thrive.
-
Ignite Your Potential: Lana
Lana is motivated to solve rare diagnosis puzzles for millions of patients – all by seeing the bigger picture through their eyes.
-
Ignite Your Potential: Denise
Denise explains how Glauber, her beach tennis coach, gives her the confidence to always push for better.
-
Ignite Your Potential: Eldar
Eldar’s dad taught him to always persevere and push for better outcomes – even when the odds are stacked against you.
-
Ignite Your Potential: Paul
Watch Paul discuss how his partner’s uncle inspired him to never settle and always put patients at the center of what we do.
-
Ignite Your Potential: Sam
Sam’s mom pushed her to be a better listener and always put patients at the center of what we do.
-
Ignite Your Potential: Cordula
Cordula’s manager, Paul, always had faith in her. That’s what helped her to believe in herself. Now she’s helping her colleagues transform medicine.
-
-
What makes Sanofi unique?
Sanofi is more than a global biopharmaceutical company, we are a place where purpose, people, and innovation come together.
Rejoignez notre communauté
de talents
Que pourrions-nous accomplir ensemble ? Chaque Sanofien travaille sur des projets qui ont un véritable impact sur la vie des gens.
Inscrivez-vous dès aujourd'hui et découvrez nos dernières opportunités dès qu'elles seront disponibles.