Specialist Manufacturing - 33616

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.
Job 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.
• Lead and oversee operational excellence projects and transformation initiatives of medium to high complexity to support the continuous improvement of the ES RMD Quality Record Management.
• Lead continuous improvement projects that deliver measurable gains in quality, efficiency, and alignment within Amgen. Apply the knowledge, skills, and tools of project management / Operational Excellence (OE) to ensure optimal project performance and continuous improvement initiatives.
• Create, own, and maintain visual management tools and global processes that use digital capabilities, like Smartsheet, Tableau, Miro, and similar tools
• Coordinate and facilitate cross-functional workshops that may be required by the initiatives, leveraging Miro.
• Partner with internal and external cross-functional teams, manage related meetings, minutes, action items, escalations, and drive the decision-making process.
• Project management of resource planning, generating and reporting metrics / Key Performance Indicators, and presentation materials for management reviews and governance meetings.
• Responsible for building project plans and team assignments using Gantt charts, estimating project cost and adhering to budget, advising and supervising work efforts daily, identifying resource needs, performing business quality reviews, and appropriately calating functional, quality, timeline, and cost issues.
• Use project management processes, software, and methodologies to ensure projects are delivered on time, within budget, adhere to high-quality standards, and meet internal and external customer expectations.
• Coordinate communication with all areas of the enterprise that impact the scope, budget, risk, and resources of the work being managed.
• Develop and apply change management plans for the implementation of initiatives.
• Manage and lead medium to sophisticated projects, comfortable with change and uncertainty.
• Applied Process Expertise
  • 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.
  • Provide troubleshooting support.
  • Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

• Process Monitoring
  • Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
  • Provide support of timely execution of the process monitoring quarterly reports.
• Non-Conformance and CAPA
  • Ensure that all Non-conformances are triaged within the established goal.
  • Responsible for authoring investigation reports.
  • Responsible for execution of corrective actions.
  • Responsible for managing NC/CAPA closure within established goal.
  • Monitor and communicate incidents trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Process Validation
  • Assist with generation of process validation protocols and reports.
  • Assist with the execution of the process validation.
  • Support collection and analysis of process validation data.
• Regulatory
  • May participate in regulatory inspections
  • New Product Introductions & Process or Equipment Modifications
  • Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Change Control
  • Assist manufacturing change owner on CCRB packages impacting the process.

Preferred Qualifications

• Extensive knowledge and expertise in the use of project management methodologies and tools, resource management practices, and organizational change techniques.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook) with also strong analytical skills and knowledge of tools within Smartsheet, Tableau, Miro, and other software programs.
• Demonstrated experience with building dashboards, forms, automation, etc, in Smartsheet.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including presentation skills) with the ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Demonstrated ability to deliver results through living the Amgen values.
• Ability to maintain remote working relationships with colleagues at other Amgen sites.
• Skills in leading and managing cross-functional teams in diverse cultures and geographic locations, and conflict resolution with diplomacy.

Education

• Doctorate degree OR Master's degree and 3 years of Operations experience OR Bachelor's degree and 5 years of Operations experience or Associate degree and 10 years of Operations experience or High school diploma / GED and 12 years of Operations experience. Any Engineering, typically Industrial Engineering is more suited for this role.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.