Job Description: Summary:
Client (Client) is a diversified specialty biopharmaceutical company whose mission is to Client, develop and deliver innovative medicines that help patients prevail over serious diseases.
Client is looking for consultant engineer responsible for development, maintenance and support of the global Manufacturing Execution Systems (MES) solution-Syncade that is utilized globally across the Digital Plant manufacturing network to produce medicine.
This includes successful delivery of projects and continuous improvement initiatives focused on effectiveness and cost reductions in manufacturing operations.
Responsibilities:
Syncade MES solution scope includes software(recipe) components, configuration, recipe and object libraries, interfaces, reports and any customizations that support the Digital Plant manufacturing operations
Responsible for delivering simple to complex changes to application or recipe build within the MES solution-Syncade(emerson)
Partner with business partners to understand business requirements and translate to MES solutions
Responsible for assessing the risk and impact that changes, patches, outages or other events can have to the MES solution.
Responsible for testing MES syncade recipes that interfaces to ERP (Enterprise resource planning), CMMS (Asset calibration system), Quality execution systems including LIMS, Process control systems (DeltaV,etc.) and other digital solutions.
Ensuring compliance with data integrity and computer system validation requirements and regulations as a part of MES recipe Development and testing.
Understand changes that impact validated state of application and underlying infrastructure.
Qualifications
5+ years' work experience, with at least 5 years' experience in GMP execution systems
Bachelor of Science in an Engineering or other Science discipline, Computer Science, or Management Information Systems.
Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, MES, PAT, OSI Pi Data historian, etc.) in a regulated manufacturing environments in pharmaceutical or biotech industry.
Strong domain expertise in the application of IT to manufacturing, including a broad understanding of processes and how they are supported by IT tools and systems.
Strong knowledge of regulatory landscape and demonstrated experience with software validation.
Additional Job Requirements:
None
The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.