Process Systems Engineer
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Job DescriptionThe Process Systems Engineer provides input to the design and development for electronic Process systems including electronic batch records (MES), DeltaV, OSI Pi, and process monitoring systems.The Engineer works with Digital Plant, IT, Manufacturing Operations, and process subject matter experts to deliver process Changes.Apply manufacturing process expertise and process system technical knowledge during change management.Own User Requirements for process systems.Ensure consistent execution of system modifications and changes.Ensure adherence with governing documents related to change management.Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MSAT to ensure change initiatives are driven to closure and migrated to the production area in a timely manner.Owns the lifecycle of process system changes.Works with site functional teams, including manufacturing, engineering, warehouse, and quality assurance to gather user requirements for change development.Understanding of DeltaV and MES library objects. Use that understanding to direct changes to associated systems.Develop documentation to support the qualification of the DeltaV and MES recipes, including test scripts and User Requirements.Execute testing of the changes in the development environment to ensure functionality.Support Chain of Identity program and ensure it is maintained within the process systems.Manage User Acceptance Testing process for system qualification.Develop and deliver reports from reporting software.Provide technical support for manufacturing operations, investigations and change controls as a process system subject matter expert.Responsible for coordinating any of the changes to those electronic batch records, main functions are project managing the changes and validation testing of the changes that are made by the development and coding team.Update technical documents Use of critical thinking or problem-solving skills to come to a solution for some of the batch records.Pull data from different reporting systems or generate presentations to present to a certain audienceWork cross functionally with Manufacturing, IT, Validation, and Quality counterparts to move the changes through the system. Own the life cycle of the changes from start to finish. QualificationBachelor's Degree in a related field from an accredited college or university required (science or engineering preferred)Strong project management skills are needed.Minimum of 1 year of experience with project coordination and cross-functional team leadership preferred.Minimum 1 year of experience support DeltaV, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.Minimum 1 year of experience supporting electronic batch records, preferably Syncade MES.3-5+ years of relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.Knowledge of DeltaV and process automation is required.Syncade MES is a plus.A good collaborator with both on and offsite teams. Requires excellent project management skills and coordination with stakeholders, as well as leadership, enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs.Must be goal-oriented, flexible, and a subject matter expert in process systems.Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is required.Top Skills:Manufacturing or Process backgroundElectronic batch recordsProject management skillsValidation exposure Hands on exp. with MES BenefitsHealthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.Synectics is an equal opportunity employer.