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16 days ago
Simply Recruitment Partner
Salary band: $10k - $15k
Location: North America, United States, Texas, Waco
Job type: Permanent
Contact: PSC Biotech Corp.
Category: Engineer
Job Description

PSC Biotech is a worldwide consulting organization specializing in staff augmentation and projects in Engineering, Validation, Technical Services and other disciplines in the life sciences industry, currently we are looking for Validation Engineers for our client in Texas.

Responsibilities
Responsible for ensuring quality systems through execution of validation activities including:

  • Writing and executing protocols and test cases for validations.
  • Coordinating testing and documentation of projects.
  • Identifying exceptions, performing effective root cause analyses, and implementing effective corrective actions
  • Writing validation final reports.
  • Responsible for planning and executing multiple assigned validation activities simultaneously, which may include automation, mixing/cleaning, environmental, media program, filter sterilization, autoclave, SIP, VHP, ETO and gamma sterilization, as well as significant projects for new lines, new products or process improvement.
  • Other responsibilities include completing all validation-related documents required which meet all internal and external regulations to support product submissions; evaluating state of the art equipment, processes, and implementing changes as needed; providing scientific/technical expertise for process improvements and innovative approaches to production and validation activities, including technical improvements and utilization of labor, raw materials and equipment; and participating in establishment resource requirements and executing assigned validation activities within the budget limitations.
  • Thorough knowledge of applicable validation regulatory guidance to validation subject matter (e.g. GMPs, sterilization, cleaning validation, process validation).
  • Experience using Kaye validators preferred.
  • Position requires previous experience writing master plans, validation protocols, qualifications, technical reports, and specific validation procedures.
  • Ability to independently lead validation-related projects with minimal supervision and appropriate escalation of issues.

Requirements

  • Bachelor degree in Engineering or in a similar field required
  • 3+ years of work experience in a Pharmaceutical or Biotech industry (preferably FDA-regulated)
  • Applicant must be knowledgeable about regulatory/compliance/validation issues
  • Must have strong written and oral communication skills.
  • Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols is required.
  • We do not accept unsolicited resumes from third-party recruiters.
Company Description
PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.

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