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QCG1796 Sr. Validation Scientist

Quality Consulting Group
00777, PR
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico.

Responsibilities:

  • Able to troubleshoot systemic validation issues.
  • Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
  • Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
  • Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
  • Develop validation engineering policies and procedures that affect multiple organizational units.
  • Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
  • Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
  • Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
  • Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Qualifications:

  • Bachelor Degree
  • Five (5) years of relevant Experience
  • Robust knowledge and proven successful track execution of Good Manufacturing Procedures.
  • Hands on experience with , Change Control, Trackwise and Equipment Interphase (HMIs) systems.
  • Detailed technical understanding and Experience in Cleaning Validation Execution, Develop Protocols, Technical Reports, Validation Summary Reports and Validation Master Plans.
  • Skilled in performance of GMP production operations.
  • Regulatory knowledge and interactions.
  • Participate and help lead cross-functional teams.
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Excellent written and oral communication skills in English and Spanish.
  • Available to work: 1st shift, 2nd/3rd or weekend duty, to support execution of validation studies.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Quality Consulting Group

Address

00777, PR
00777 USA

Industry

Manufacturing

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