Sr. Validation Specialist

Job Location:

Manati, Puerto Rico

Job Description:

Job Description

The Sr. Validation Specialist/Engineer will be working with the Validation team developing and executing validation activities and protocols.  The selected candidate must be knowledgeable and experienced in the following:

-Experience in pharmaceutical facilities qualification in a manufacturing environment.

-Background in pharmaceutical products in a manufacturing environment.

-Experience in the validation requirements, activities, and deliverables for the design, implementation, and operation of Freeze-Thawing Units.

-Strong knowledge of cGMP regulations.

-Good technical documentation skills.

-Must be an expert at the entire validation life cycle:

  • Facilities commissioning
  • URS
  • SAT/Report
  • Initial Risk Assessment
  • Validation Plan
  • Design Specifications
  • SOPs
  • IOQs
  • Final Risk Assessment
  • Traceability Matrix
  • Validation Plan Summary Report

Job Requirements:


Required Experience:

  • 5 to 10 years of experience in the pharmaceutical or biotechnology  industry.
  • Capable of working independently with minimal supervision, and communicating.
  • Great technical writing and communication skills
  • Effective interpersonal and problem solving skills
  • Commissioning and Qualification
  • Protocols Generation and Execution
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
  • Must be available to work extended hours and rotating shift as required.

Required Education:

  • Bachelor's Degree in Science or Engineering (Chemical, Electrical, Computer, Industrial or Mechanical) preferred.

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, USA Inc. is an Equal Employment Opportunity employer.

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Contact Information:

Contact: Human Resources
Validation & Engineering Group


December 29, 2017
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