Job Title: MES Specialist
Location: Swiftwater, PA
About the JobIn 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, interfaces, updating design documents, executing testing, troubleshooting events, and being a part of the MES on-call support.
Main ResponsibilitiesThe MES Specialist 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 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 operations staff to ensure proper execution of systems. Perform regular training sessions with operations. Provide ongoing support post-implementation. Provide mentorship and training for new MES Specialists.
- 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.
- On-Call Support: Be available to provide "on call" support during off-shift hours, based on a rotating schedule, to support manufacturing operations.
About YouBasic QualificationsEducation:- Bachelor's degree in engineering, Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, Health Sciences, or a related field in the biopharma sector.
- 1+ years of experience in MES/eBR and Automation support within biopharma or related industries.
- Hands-on experience and skill in MESSiemens OpCenter with strong expertise with DCS (DeltaV), SCADA (Aveva), PLCs, and related automation technologies in a manufacturing context.
- General knowledge/familiarity with Process Control Systems: DCS (DeltaV), SCADA (Aveva), PLCs
- Machine connectivity experience with data acquisition from PLCs into higher level applications like Historian, ERPs, etc.. using current technologies like OPC.
Technical Skills:- MES Platform Configuration (Siemens OpCenter)
- Electronic Batch Record (EBR) Support
- DCS/SCADA Systems (DeltaV, Aveva)
- OPC & Data Integration (Historian, ERP connectivity)
Soft Skills:- Technical/Project Leadership
- Team Collaboration
- Analytical Skills
- Communication (cross-functional teams; occasional stakeholder interaction)
The salary range for this position is:
$85.500,00 - $123.500,00
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.
