Job Description:
Job Title: MES Engineer- Vaccines
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.
In this role, you'll join the Manufacturing Systems & Automation department at our Swiftwater site, working directly with the site manufacturing execution system (MES) automation day to day support. This role will provide electronic batch record (EBR) support and configuration of the site MES. The role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional departments. This includes implementation of changes to the EBR, automation systems, updating design documents, executing testing, troubleshooting events, and being a part of the site automation on-call support.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
The MES Engineer will oversee manufacturing execution system and automation within the whole site. Key responsibilities include:
MES Solutions:
- Develop MES/EBR solutions including recipe, configuration, and/or system changes to meet business requirements.
System Integration:
- Ensure seamless integration of automation systems with digital applications to support production, quality control, and data management.
Deliverable Accountability:
- Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test protocols, and system validation.
- Work closely with the client to understand their needs and develop strategies tailored to their organization through site assessments.
Vendor Coordination:
- Collaborate with procurement and project teams to select vendors for manufacturing systems and automation.
- Ensure alignment with project quality and regulatory standards.
Risk and Compliance Management:
- Identify and proactively manage risks.
- Ensure compliance with GMP to minimize disruptions to timelines and costs.
Training and Support:
- Develop and deliver specialized training materials for staff to ensure proper operation and maintenance of automated systems.
- Provide ongoing support post-implementation.
Collaboration and Documentation:
- Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer departments to capture and document detailed requirements.
- Perform application support duties for the manufacturing execution system (MES) as needed.
Standards and Best Practices:
- Develop standards and best practices for development and validation activities.
- Lead cross-functional teams through design reviews and user acceptance testing during the development change and validation process.
Development and Implementation:
- Perform and communicate planning, development, peer review, and testing solutions for recipe creation and modification.
- Execute development and implementation of new changes across the Manufacturing systems based on requirements, specifications, and developed software solutions.
Operational Meetings:
- Participate in facility operational meetings to ensure facility reporting needs are met.
Mentorship and Training:
- Provide mentorship and training for new MES engineers.
- Assure quality customer service to all customers.
On-Call Support:
- Be available to provide "on call" support during off-shift hours, based on a rotating schedule, to support manufacturing operations.
About You
Experience:
- Automation and Engineering: Minimum 8 to 10 years of direct experience in MES/eBR and Automation support within biopharma or related industries.
- Process Control Systems: Strong expertise with MES (Siemens OpCenter), DCS (DeltaV), SCADA (Aveva), PLCs, and related automation technologies in a manufacturing context. Machine connectivity experience with data acquisition from PLCs into higher level applications like Historian, ERPs, etc.. using current technologies like OPC.
Soft and Technical Skills:
- Leadership & Team Collaboration: Proven leadership and ability to collaborate effectively with cross-functional teams.
- Analytical Skills: Strong problem-solving abilities and expertise in designing robust system integration architectures.
- Communication: Effective communication skills for engaging diverse stakeholders across projects.
Education:
- Bachelor's degree in engineering, Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, Computer Sciences, or a related field in the biopharma sector.
Languages:
- English: Proficiency in both written and spoken English.
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.
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.
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