29 days old

Process Validation Engineer

ICQ Consultants Corp
Southborough, Massachusetts 01745
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift, Overtime

The candidate will be a part of the ICQ Consultants team and will be responsible for the development and execution of process validation protocols and final summary reports with a focus on process transfer.

EDUCATION & EXPERIENCE REQUIREMENTS

B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.

RESPONSIBILITIES

  • Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
  • Customarily and regularly exercises discretionary and independent judgment in performing the job.
  • Participate in training to ensure continued accreditation.
  • Maintain a safe working environment for self, team members and clients operational or administrative staff.
  • Other tasks in alignment with your skills and competencies as required by the project, client and/or management.

Requirements

REQUIRED EXPERIENCE

  • Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
  • Must be a self-starter, detail oriented and able to work independently with minimal supervision.
  • Excellent troubleshooting skills; ability to react quickly to understand and solve problems.

REQUIRED SKILLS

  • 3+ years of Process Validation experience with process operational areas such as cell banking, cell culture/fermentation, purification, final fill, packaging etc.
  • Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
  • Direct experience within the following areas:
    • Technical Transfer
    • Process Control Strategies
    • Validation Master Plans
    • Developing a Process Performance Qualification (PPQ) protocol
    • Executing a PPQ protocol
    • Sampling
    • Mixing Studies
    • Hold Studies
    • cGMP
    • Aseptic processing
    • Client interactions (external and internal)
    • Standard Operating Procedure (SOP)
    • Change Control,
    • Deviations
    • Risk Assessments
    • CAPAs
    • GMP investigations

Categories

Posted: 2022-10-28 Expires: 2022-11-27

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Process Validation Engineer

ICQ Consultants Corp
Southborough, Massachusetts 01745

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