EM Process Specialist - 2407015672W

　　DESCRIPTION/RESPONSIBILITIES:DescriptionKenvue is currently recruiting for:External Manufacturing Process Specialist

　　This position reports into EM Senior Site Leader and is based at the Fort Washington, PA Campus

　　What You Will DoThe External Manufacturing Process Specialist is responsible for supporting quality processes in the external manufacturing network and mapping of streamlining and improvements (ex. investigations, change controls, etc)

　　Key ResponsibilitiesThe External Manufacturing Process Specialist will have the following responsibilities:* Be accountable for coordinating investigations associated with various External Manufacturing Site non-conformances, and Out-Of-Specification results.* Provide leadership to their assigned sites by leading cross functional alignment on investigations, initiating system entries, documenting nonconformance summaries and initiating action items for deviations.* Review External Manufacturer's investigation report and support documents, understand the product quality issues, gather relevant investigation information, analyze data and track the investigation progress.* Present documented investigation findings to EM Quality Assurance and Operations groups for approval.* Be responsible for tracking all open investigations at their sites, maintaining metrics and facilitating investigation discussions across Kenvue and External site.* Drive and provide expertise in resolution of roadblocks that prevent optimal effectiveness of the investigation process; and will work with other corporate units as required.* Perform metrics analysis and present to management and x-functional departments to highlight workload, urgent Investigations and Action Items* Contribute to improvement of the Investigation processes by identifying opportunities and assisting in developing and implementing solutions.* Train on the EM Change Control Process and lead the facilitation of EM Operations Change controls as needed.* Author CC requests with input from the EM Site Leaders, Quality Account Managers (QAM), Technical Operations, Sourcing Leads, and other Subject Matter Experts (SMEs)* Interface with subject matter experts to align on CC strategy, language, and deliverables.* Facilitate and monitor CC's through all lifecycle phases in a timely manner to meet business needs* Communicate CC status through regular email and meeting updates to CC team and deliverable owners* Coordinate deliverables execution and ensure CCs and Action Items are closed in a timely manner or to meet business needs.* Enable reliability of supply by driving critical CC's to execution and completion with a sense of urgency* Act as the project manager for complicated CC's that require oversight and/or time urgency

　　QualificationsWhat We Are Looking For

　　Required Qualifications* Bachelor's Degree is required with a focused degree in Science or Engineering Technologies preferred.* A minimum of 6 years of experience in a GMP regulated environment (pharmaceutical etc.) is required. Technical writing background is preferred.* Experience with pharmaceutical or consumer manufacturing (processing/packaging, etc.) is required.* Ability to handle multiple complex investigations simultaneously is required.* The ability to read, analyze and interpret common scientific and technical documents is required.* Organizational skills and the ability to adapt to a fast-paced environment with changing priorities is required.* Ability to effectively present information and communicate clearly to all levels of management is required.* Previous experience working in cross functional matrix environment with an ability to influence without authority is required.* Demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple assignments, prioritize and adapt to business needs with a sense of urg ncy, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills, problem-solving and Lean mindset.

　　Desired Qualifications* Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred.* Ability to work directly with external manufacturing sites under limited supervision is preferred.* Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are preferred).* Knowledge of process excellence or other comparable process and root cause problem solving methodologies is preferred.

　　What's In It For You* Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!* Learning & Development Opportunities* Employee Resource Groups

　　Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.