CINCO Engineering

Role Description With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Qualifications - Experience in manufacturing, process development, or quality assurance in the Biotech or pharmaceutical industry with progressively increasing responsibility. - Demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems. - Proficient and experienced in owning Change Controls. - Project Management and/or Quality Management skills and experience. - Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English. - Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work, and communicate effectively. - Proficient with Microsoft Office Tools (Word, Excel, PowerPoint, Project, Teams, Outlook). - Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, Vevaa, or a comparable quality system. - Experience navigating and executing transactions in SAP (ERP) system. - Strong negotiation skills when working with external suppliers and internal team members. Requirements - Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. - Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. - Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. - Responsible for managing NC/CAPA closure within established goals. - Review equipment/system Root Cause Analysis investigations and support trend evaluations. - Assist with generation of process validation protocols and reports. - Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. - Assist manufacturing change owner on CCRB packages impacting the process. Education - Bachelor's degree and 5 years of Manufacturing Operations experience or associate’s degree and 10 years of Manufacturing Operations experience.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking a highly motivated and detail-oriented Senior Data Analytics Specialist to support the development and implementation of data repositories and analytics tools for pharmaceutical regulated environments operating under Good Manufacturing Practices (GMP). This role will focus on enabling data-driven insights across manufacturing and quality domains, ensuring data integrity, compliance, and effective use of analytics to support operational and quality decision-making. - Analyze business needs and requirements for data and analytics to support regulatory filings. - Identify, classify, and map data sources. - Build data lineage diagram from data source to analytics ready datasets. - Determine data curation requirements to help organize, clean, manage, and maintain data for reliable analytical use cases. - Provide support for technical activities such as building data integration, designing data architecture, and data transformation and processing. - Develop data governance standards to comply with company and industry best practices. - Lead development of key project documents such as user requirements, design specifications, and configuration specifications. - Lead development of test scenarios and scripts in partnership with business, technical, and validation team members. - Lead test execution according to test protocols. - Provide support for development of standard operating procedures and other documentation required to go-Live. - Monitor execution of testing and relay results to technical team to address issues. - Provide support for training business teams for Go-Live. - Development of training materials as needed. - Provide regular updates to project team. Qualifications - Bachelor's Degree. - Minimum of 5-10 years of IT experience working in the role of business and technical analyst with a focus on data, business intelligence, and analytics projects. - Experience working in Biotech/Pharma (Regulated Industry). - Experience with developing requirements, design, and testing documents. - Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment. - Experience with design and development and usage of data repository and analytics platforms. - Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries). - Experience with database (SQL) and ETL development. - Experience with cloud environments (AWS, Azure). - Experience with usage of process analytic software is a plus (Aveva, Seeq). - Knowledge of System Support/System Administration, Communications, Project Management, Training, Computer System Validation, Business Requirements Documentation. - Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments. - Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation). - Experience with system administration responsibilities. - Experience with helping lead data analysis and engineering projects. - Ability to work under tight timelines, communicate and work across teams in a collaborative manner, and work independently with minimal supervision. - GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting. - Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools. - Understanding of data modeling tools.

• The MES Specialists will be responsible for the design, administration, and ongoing optimization of PAS-X systems in manufacturing environments. • Analyze business and operational requirements to configure and design PAS-X solutions. • Develop workflows, master batch records, and system specifications tailored to client needs. • Ensure seamless integration of PAS-X with other systems, such as ERP, SCADA, and LIMS. • Act as the System Owner for PAS-X implementations, ensuring operational excellence and compliance. • Monitor system performance, resolve issues, and implement enhancements. • Maintain comprehensive documentation, including system configurations and validation protocols. • Oversee user management, role-based permissions, and data security within PAS-X. • Coordinate software updates, patches, and system upgrades. • Develop and implement protocols for system backups and disaster recovery. • Lead PAS-X implementation and upgrade projects, ensuring adherence to scope, timeline, and budget. • Collaborate with cross-functional teams, including IT, automation, and production. • Manage vendor relationships and ensure the delivery of high-quality solutions. • Conduct risk assessments and establish mitigation plans. • Provide end-user training on PAS-X functionalities and workflows. • Offer ongoing support and troubleshooting to ensure smooth system operation. • Drive adoption of system best practices across the organization.