Sr. Associate, Lifecycle Management

Alcon•Fort Worth, TX

53d•Onsite

About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Associate, Life Cycle Management supporting the MTO Packaging Engineering Team in Fort Worth, TX, a typical day will include: Perform specialized tasks and conduct independent research to optimize lifecycle management outcomes, contributing to project goals with advanced skills. Assist in the preparation and submission of regulatory documents, ensuring compliance with relevant regulations. Support cross-functional teams in meeting lifecycle management requirements and work with various departments to impact the efficiency and success of product lifecycle management and regulatory submissions. Provide product portfolio analyses and reports to management committees for decision-making support. Make decisions within the scope of assigned tasks, requiring advanced knowledge, analytical skills, and self-direction. Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintain accurate and complete documentation, ensuring rigorous quality control. Complete all required training and contribute to the overall compliance of the organization, committing to continuous improvement in operations. Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Manage Product and Process Change (PPC) activities related to all incoming chemical changes. Develop and implement strategic PPC plans tailored to each change. Present PPCs at Change Control Board (CCB) meetings to ensure alignment and approval. Collaborate with cross-functional teams to drive timely execution of PPC tasks. Facilitate the release of chemical-related changes in accordance with production goals and operational timelines. Provide support to Packaging Engineering (PKE) team members in executing PPC activities, ensuring alignment with project timelines and organizational objectives. Lead the execution of New Product Launch Requests (PLR), Existing Product Change Request (EPCR) and Divestment/Rationalization initiatives, ensuring timely, compliant and high-quality supply. Own and maintain the package component specification system including oversight of all related documentation. Ensure accurate and timely entry of all specifications into the component specification system. Coordinate initial product deliveries to external customers for New Product Launch or Existing product change projects. Engage with stakeholders within FWN, proactively aligning with SME's across functions including Demand planning, QA Compliance, Site Engineering & Production. Apply basic project management principles, concepts, and practices to manage one or two projects at a time. Proactively identify, escalate and manage project deviations to ensure on-time and successful implementation of project plans. Understand key systems including Kiteworks, CLEAR, Ensur, SAP and Master Data. Implement CAPA's for LCM related deviations using TrackWise CAPA system as needed.

Requirements

Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
The ability to fluently read, write, understand and communicate in English
2 Years of Relevant Experience
Worksite location: Onsite
No Travel
Relocation: No
Sponsorship Assistance: No

Responsibilities

Perform specialized tasks and conduct independent research to optimize lifecycle management outcomes, contributing to project goals with advanced skills.
Assist in the preparation and submission of regulatory documents, ensuring compliance with relevant regulations.
Support cross-functional teams in meeting lifecycle management requirements and work with various departments to impact the efficiency and success of product lifecycle management and regulatory submissions.
Provide product portfolio analyses and reports to management committees for decision-making support.
Make decisions within the scope of assigned tasks, requiring advanced knowledge, analytical skills, and self-direction.
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintain accurate and complete documentation, ensuring rigorous quality control.
Complete all required training and contribute to the overall compliance of the organization, committing to continuous improvement in operations.
Manage Product and Process Change (PPC) activities related to all incoming chemical changes.
Develop and implement strategic PPC plans tailored to each change.
Present PPCs at Change Control Board (CCB) meetings to ensure alignment and approval.
Collaborate with cross-functional teams to drive timely execution of PPC tasks.
Facilitate the release of chemical-related changes in accordance with production goals and operational timelines.
Provide support to Packaging Engineering (PKE) team members in executing PPC activities, ensuring alignment with project timelines and organizational objectives.
Lead the execution of New Product Launch Requests (PLR), Existing Product Change Request (EPCR) and Divestment/Rationalization initiatives, ensuring timely, compliant and high-quality supply.
Own and maintain the package component specification system including oversight of all related documentation.
Ensure accurate and timely entry of all specifications into the component specification system.
Coordinate initial product deliveries to external customers for New Product Launch or Existing product change projects.
Engage with stakeholders within FWN, proactively aligning with SME's across functions including Demand planning, QA Compliance, Site Engineering & Production.
Apply basic project management principles, concepts, and practices to manage one or two projects at a time.
Proactively identify, escalate and manage project deviations to ensure on-time and successful implementation of project plans.
Understand key systems including Kiteworks, CLEAR, Ensur, SAP and Master Data.
Implement CAPA's for LCM related deviations using TrackWise CAPA system as needed.