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Sr. Validation Engineer

Job Attributes

Job Id:

33883

Job Category:

Biotechnology

Job Location:

Philadelphia, PA  19114

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Companies is seeking a Sr. Validation Engineer in Philadelphia, PA to work for a global pharmaceutical company. The project is scoped to be 12 months with possibility for extension.


  • Participates in system design and commissioning project phases.
  • Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification.
  • Generates Validation Project Plan for complex projects and systems
  • Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments
  • Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes.
  • Authors Validation Protocols and Reports for Controlled Temperature Units.
  • Supports Periodic Assessments on required frequency intervals
  • Performs Revalidations on required frequency interval
  • Resolves technical issues encountered during study execution
  • Schedules resources to approve and execute validation documents
  • Participating in SOP development as needed
  • Supports equipment start-up, shakedown, and cycle development
  • Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle
  • Implements/maintains governing cGMP procedures
  • Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures
  • Author and review change control documents


Responsibilities of the Validation Engineer include:

  • Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. 
  • Assist with SOP review and upgrades
  • Supports the execution of equipment qualifications and validation protocols
  • Thorough understanding of test method validation and updates
  • Proven IQ/OQ/PQ work experience 
  • Supports calibration, equipment qualification and validation activities


Qualifications for the Validation Engineer include:

  • 5+ years experience in equipment validation
  • Regulated industry experience, medical device preferred
  • Install/implement validation processes
  • IR machine experience 
  • Understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
  • Strong working knowledge of 21 CFR Part 11 compliance
  • Ability to interact effectively across departments


Compensation for the Validation Engineer includes:

  • $55-$65/hr on a contract rate
  • Full Benefits Package including medical, dental, vision, 401K, and paid time off

Apply Now

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New Search

Job Id:

33883

Job Category:

Biotechnology

Job Location:

Philadelphia, PA  19114

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions