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Job Title:  Process Validation Engineer

Req ID:  30830
Job Category:  Engineering

St. Louis, MO, US, 63133

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

Manage the validation activities required to comply with current FDA/ISO regulations in St. Louis (Aseptic and Non-Aseptic Processes) and oversite of Validation Activities for other STERIS Facilities.  Drafts, reviews, approves, and facilitates completion of validation protocols. Coordinate and manage validation project execution for equipment, critical utility, process, cleaning, and computer related systems. Ensure protocols, records, and procedures are in compliance with 21 CFR 11, 210, 211, & 820 and current Good Manufacturing Practices (cGMP).  Facilitates resolution of deficiencies that prevent successful validation of processes, conducts DOE’s, controlled Engineering experiments, etc.  Works closely with R & D to release and validate projects from R & D to Manufacturing. 

Duties

  • Write process and utility equipment validations, which include (IQ, OQ, PQ) and the Final Report.
  • Write and implement cleaning validations.
  • Write User, Functional, and Design Specifications
  • Develops and maintains “Clean & Dirty Hold Times” for all process Equipment
  • Develops and Maintains Process/Performance Validation and Cleaning Validation Strategy Documentation.
  • Develops and Maintains Process Simulation documentation.
  • Work closely with RA/QS to complete the process validation of manufacturing equipment.
  • Maintain extensive Validation Master Plan for accuracy and completeness.
  • Conduct DOE’s and FMEA’s.

  • Coordinate Engineering and Manufacturing staff to support the required validation.
  • Ensure that transfers of R & D projects meet equipment validation requirements.
  • Initiate and evaluate all available technical data in order to develop conclusions derived from studies undertaken.  Provide analysis, evaluation, and interpretation of data.
  • Utilize appropriate project management skills and tools to meet timelines and provide progress updates to management.
  • Manage and maintain equipment change control log and it affect on new and existing protocols.
  • Provide and detail validation activities to both customer and regulator audits.
  • Provide direction to assigned staff in carrying out their duties as required.    
  • Other duties as assigned which may include process development, project management, process optimization projects or other duties to optimize the plant operations.
  • Collects and organizes technical specifications, data and information required for capital/construction projects requiring validation.
  • Writes procedures (SOP’s), investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments.

Required Experience

  • Bachelor's Degree or a minimum of five years' relevant work experience required.  
  • Minimum of 1 year validation experience or equivalent plant/process engineering experience that is demonstrated to add value to this position. 
  • Must have a sound knowledge, application and proper implementation of technical, quality and scientific principals necessary to meet industry and customer requirements in a team environment. 

Skills

  • Possess effective skills for developing, performing, evaluating, troubleshooting operating systems and controls. 
  • Requires excellent interpersonal skills and strong team orientation. 
  • Requires excellent analytical, oral, and written communication skills.
  • Well-developed knowledge of the pharmaceutical industry standards and requirements (cGMP/FDA/ISO)
  • Demonstrated project management skills with the ability to  form a team, establish processes, timelines, objectives, Gantt charts, and  managing processes, meetings and establishing goals.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  30830
Job Category:  Engineering

St. Louis, MO, US, 63133


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