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Entry Level Validation Engineer - 1171
Job Description:

PSC Biotech is a leading cGMP consulting company.  For over 19 years we have been engaged in providing laboratory, project, process, and validation support to top-tier pharmaceutical and biotech companies.

 

Entry Level Validation Engineer wanted to train on GMP facilities and cGMP requirements. In addition, applicant will be trained on writing technical reports, and Validator Software. Applicant will be working in a biotech/pharmaceutical environment as a consultant/contractor for various clients. He/she will be working closely with client's employees on various projects and various GMP facilities to help client with validation issues. Applicant must be willing to learn new ideas, techniques and systems. Applicant must be willing to commute to clients' manufacturing sites.

 

Responsibilities:

 

  • Assist in preparing and reviewing Validation Life Cycle documentation:
    Validation Plans, User Requirements Specification, Impact Assessments, Design Specifications, Design Qualification, Installations Qualifications, Operational Qualifications, User Acceptance Testing, Performance Qualifications, Process Validation protocols.
  • Assist in executing validation protocols (DQ, IQ, OQ, UAT, PQ & PVs).
  • Assist in preparing and reviewing Summary Reports.
  • Assist in performing 21 CFR Part 11 assessments required for 21 CFR Part 11 regulations.
  • Assist in preparing and reviewing protocol deviations. Perform system trouble shooting.
  • Ensure all validation documentation is in compliance with Corporate policies, local policies /SOPs and regulatory standards such as Annex 11, Annex 15, 21 CFR Part 11, cGMP, cGAMP, GDP, ICH.
  • Assist in preparing and reviewing validation SOPs and work instructions
  • Collaboration with cross functional teams including; Project Engineers, Project Managers, Quality Representative and Compliance Representative and Operational Representative.
  • Review and modify Standard Operating Procedures (SOPs)
  • Generate test procedures to validate new or previously unvalidated equipment/processes
  • Participate in and conduct any or all of the following types of validation:
    • Cleaning Validation
    • Process Validation
    • Computer Validation
    • Equipment Validation
    • SIP/CIP Validation
    • Risk Assessments

 

Requirements:

 

  • Applicant must have graduated with an engineering or technical degree from a four-year college or university
  • Knowledge on regulatory/compliance/validation issues, self-motivated, intelligent and reliable a plus but not required
  • Knowledge of PC computer OS (typically Windows), knowledge of Word and excel are mandatory.
  • Must have strong written and oral communication skills and organizational skills
  • Possess self-motivation and drive
  • Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols will be desired.
  • Applicant must also be willing to perform more sophisticated/complicated types of validation work.
  • Must be flexible and able to manage multiple priorities simultaneously
Job Listing Information
Job Code:
1171
Job Title:
Entry Level Validation Engineer
Location:
Southern CA
Number Of Openings:
1
Employment Duration:
Full-Time
Job Type:
Contract
Job Industry:
Biotech/Pharmaceutical
Work Experience:
Entry-Level
Date Posted:
05/18/2016


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