Mallinckrodt

Mallinckrodt

Senior Manufacturing / Process Engineer

CC-Port Allen - USA502, United States of America · Senior

Sponsorship not specifiedDetected 11 hours ago
Project ManagementBusiness DevelopmentExcelProcess ImprovementGMPFDA RegulatoryMedical DevicesLeadershipProblem SolvingTime ManagementPublic SpeakingWritingMicrosoft OfficeLean ManufacturingRegulatory Affairs

About the role

  • The position requires a self-starter with solid engineering expertise ranging from product/process conception through post commercialization activities and sustainment.
  • They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
  • We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology.

Responsibilities

  • include execution of capital projects, process / system engineering support / design, and general engineering support in a cGMP-regulated environment.
  • The role combines project management, technical design, and process optimization, with opportunity to grow into broader engineering leadership responsibilities.
  • Manage capital and improvement projects including scope, schedule, budget, and execution
  • Provide process engineering support including troubleshooting, root cause analysis, and continuous improvement
  • Develop and maintain engineering documentation (P&IDs, PFDs, electrical drawings, equipment files)
  • Support Manufacturing, Quality, Validation, R&D, and Business Development
  • Coordinate equipment modifications and installations including design and risk evaluation
  • Manage vendors, contractors, and engineering service providers
  • Perform field walkdowns and ensure documentation accuracy
  • Develop and maintain engineering standards, SOPs, and best practices

Requirements

  • Bachelor's degree in engineering or relevant life sciences discipline.
  • 5+ years of engineering experience in manufacturing or regulated industries
  • Experience with capital projects and process engineering
  • Management reserves the right to change or modify such duties as required.

Nice to have

  • Thorough knowledge of the pharmaceutical drug commercialization process and team-based matrix management.
  • Experience in Ultra High Purity (UHP) industrial gas organizations.
  • Working knowledge of cGMPs, including hands-on experience with their interpretation and practical application.
  • Experience applying Risk Analysis Principles in validation or quality activities.
  • Proficiency with Microsoft applications (Word, PowerPoint, Excel, Outlook)
  • Skills that will contribute to success:
  • Experience with development / support of automated systems and equipment

Skills

  • Experience working with high purity gases under high pressure and vacuum
  • Expertise / experience working with Rockwell control solutions (RSLogix, Factory Talk, VFDs, etc)
  • Effective time management
  • Strong technical writing capabilities
  • Ability to lead or deliver presentations
  • Lean Manufacturing Training or experience

Benefits

  • At Keenova, we believe that no one should be alone in their pursuit of better health.
  • We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

Company info

  • We are Keenova-keen to solve, keen to serve.
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