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Equipment Readiness Specialist

Equipment Readiness Specialist

SIB McKesson High Volume Solutions Inc.Longmont, CO, USA
8 days ago
Salary
$68,300.00–$113,800.00 yearly
Job type
  • Full-time
Job description

As part of McKesson Pharmaceutical Automation, the Equipment Readiness Engineer will primary be responsible for ensuring that manufacturing equipment meets customer requirements and performs as designed.

The specialist will conduct audits of semi-finished equipment with thorough evaluation of relevant engineering and quality documentation, working directly with production to correct any non-conformances. The specialist will help identify, troubleshoot, and close gaps in the manufacturing process, working closely with Manufacturing Engineering. Other duties include comprehensive IAT, and Customer FAT activities.

Key Responsibilities

  • Review manufacturing records and documentation, including, but not limited to, engineering documents, Quality Control Reviews (QCR), Initial Acceptance Testing (IAT), and Factory Acceptance Testing (FAT), to ensure that all regulatory and internal requirements for product quality are met.
  • Execute product validation testing. This includes, but is not limited to, the testing listed above. Knowledge and experience with PLCs and ladder logic will be a key component to this function.
  • Maintain technical documents by both completing all required documents per current Standard Operating Procedures (SOPs), and by updating current revisions with any required changes. Assist with reporting, KPI tracking, and all other document needs.
  • Process Equipment Readiness Holds as required, providing assistance and employee training as needed.
  • Complete CAPA investigations in collaboration with other departments. Follow Standard Operating Procedures (SOPs) for reporting any issues in collaboration with all other departments. Edit SOPs as necessary.
  • Write summary reports and communicates in a timely manner findings related to documentation issues, including, but not limited to, delays in receiving documentation. Other related duties as designated by the Operations Production Manager.

Minimum Requirement

Degree or equivalent and typically requires 2+ years of relevant experience.

Critical Skills

  • 2+ years work experience in pharmaceutical automation manufacturing in a similar role.
  • Solid understanding of PLCs, Ladder Logic, Engineering Schematics, and Quality Documentation.
  • Documentation Management and Finished product release expertise.
  • Ability to set up PC and software for the purpose of executing equipment testing via “Test Harness”.
  • Ability to work “hands on” with equipment in order that it meet planned requirements.

    • Additional Skills

  • Meticulous and detail oriented.
  • Experience with electronic documentation and reporting tools preferred.
  • Excellent written and oral communications skills.
  • Excellent organizational and time management skills with ability to manage several projects at once.
  • Ability to work independently and make decisions based on judgment and integrity.
  • Ability to work well under pressure, in a team-based environment.
  • Proficient user of Microsoft Office products.
  • Ability to resolve problems using exceptional analytical skills.

    • We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please

    Our Base Pay Range for this position

    68,300 - $113,800