Validation Specialist II

SGS_JOB_2345

Engineering
 Massachusetts
Shipping Validation
IQ/OQ/PQ installation qualification
operational and performance qualification
logistics
cold chain experience
Risk assessment

Contract - 6 Months (possible extension)

Location : Framingham, MA This project encompasses temporary, full-time support to be the lead point of contact for the shipping validation program during a leave period for the primary program owner. This will include tracking the status of all projects, the periodic reporting of the status of all projects to management, supporting design of transport qualification strategies, reviewing and approving transport validation deliverables and accountability for on-time delivery of transport qualification deliverables for a period of 6 months.

Job Responsibilities:

  • Lifting, temperature-controlled environments – cold room at times.
  • PPE is required, glasses, vest, personal protective equipment (PPE), protocol generation, execution and closure

Skills:

  • Familiar life cycle documentation
  • IQ/OQ/PQ installation qualification, operational and performance qualification
  • Demonstrated expertise in shipping/transport validation processes
  • Experience with logistics, customs, international shipments/ cold chain experience
  • Risk assessment, protocol generation, execution and closure.

Education/Experience:

  • BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience.
  • Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
  • Areas of experience: Shipping Validation.
  • Well-developed communication skills, both verbal and written..
  • Years of Experience: 3 - 6 Years

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