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Sr. Validation Engineer Packaging (JP7187)

LOUISVILLE, KY (Kentucky) · Biotech/Pharmaceutical
Job Title:  Validation Engineer Senior / Packaging (JP7187)
Location: Louisville, KY.
Employment Type:  Contract
Business Unit:  Louisville Kentucky Distribution Center
Duration: 3 years
Posting Date: 04/07/2020
 
3 Key Consulting is hiring a Validation Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

 
Job Description:
The ideal candidate will have 10+ years experience in the validation and have an engineering or scientific background with experience in packaging process, performance qualification, .characterizing of equipment, equipment inspection,  labelers, GMP, MES, SAP, Systech and strong leadership skills.
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects following standards and procedures. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.  Functions of this position include:
  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Develop engineering policies and procedures that affect multiple organizational units.
  • Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
  • Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.
  • Prompt and regular attendance to workplace.
 
 
Top Must-Have Skill Sets:
  • Familiarity with validation processes and documentation in a highly regulated environment.
  • In-depth knowledge of validation processes and requirements as applied to new equipment installations.
  • Packaging experience.
 
Day to Day Responsibilities:
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
  • Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
  • Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
 
 
Basic Qualifications:
  • Candidate must sit on site M-F, 8AM-5PM.
  • 9+ years of Validation Engineering experience.
  • Bachelors in Engineering or Science.
  • Must understand Quality Management Systems, Quality Validation Standards & have hands on packaging experience (worked on packaging line & understands how to handle equipment).
  • Excellent communication & leadership skills
 
 
Employee Value Proposition:
Opportunity to work among a small team, cross functional collaboration, within a team orientated environment.
 
 
Red Flags:
Lack of Serialization experience
 
 
Interview process:
Phone screening followed by Skype interview.
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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