Associate Director, Technical Operations Automation

4 weeks ago


West Point, United States Merck Full time

Associate Director, AutomationThe Associate Director, Automation within Global Clinical Supply (GCS) is responsible for developing and executing a systems and process automation strategy to support new and existing operations and supply technologies, capabilities, and performance monitoring. This role will partner regularly with Technical Operations and Capital Projects to ensure the compliant execution of automation-related aspects of our projects. This role will also lead the execution of projects within Technical Operations and upskill personnel on the basics of automation.Specifically, this role will:Lead startup of systems-related aspects of new operational facilities and equipmentLead system-related aspects of new technology deployment such as system development lifecycle (SDLC), assessments of data integrity, privacy, risk, and other aspects necessary for GxP useImplement automation solutions, including both platform technologies and associated analytics, reporting, and visualization capabilitiesDevelop and complete appropriate system validation, Change Control and testing documentation, ensuring compliance with all requirements.Support of systems upgrades/maintenance, and new software/systems installReviewing automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with Good Manufacturing Practice and safety.Partner with business areas to develop processes to enable use of technology & equipmentDeveloping and supporting corrective actions for investigations related to automation or IT systems.Conduct or support automation system-related investigations and implement necessary CAPAs.Position Qualifications:Education Minimum Requirement:Bachelor's degree in information technology, Engineering, Scientific, or related fieldRequired Experience and Skills:At least 7 years of experience in an information technology and/or operations role within the pharmaceutical industryExperience with pharmaceutical facility and equipment commissioning, qualification, and validation (CQV)Development and execution of equipment and facility automation-related CQV strategies.Strong compliance mindset and understanding of cGMP, including FDA and EMEAWorks effectively across boundaries to build strong collaborative relations with other groupsDirect support of validation activities and compliance-related requirements functions.Willing to constructively challenge the status quo and explore continuous improvement opportunitiesStrong abilities in Stakeholder Management and building and strengthening cross-functional networksExcellent communication skillsPreferred Experience and Skills:Experience with Operational Excellence methodology e.g. Six Sigma and Lean methods principles and toolsLeadership of cross-functional teams through project planning, execution, monitoring, and closeout phases to deliver successful completion to project target milestone datesExperience with SAP or other production softwareNetworking, Virtual Machines, Database management and other general OT & IT administration.Required Skills: Accountability, Applied Engineering, Automation, Change Management, Combination Products, Communication, Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), IT Operation, Leadership, Manufacturing Scale-Up, Mentorship, Operational Excellence, Packaging Engineering, Performance Monitoring, Pharmaceutical Manufacturing, Preventive Maintenance, Process Optimization, Production Standards, Risk ManagementPreferred Skills:Salary range for this role is $126,500.00 - $199,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.



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