Process & Validation Engineer

3 weeks ago

king of prussia, United States LAPORTE Full time

Position Summary:

Process & Validation Engineer – King of Prussia, PA


The Process & Validation engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas. The Process & Validation engineer will ensure the equipment/system and validation programs are compliant with client’s global/site standards and industry practices.


The Process & Validation engineer will live in or near King of Prussia, PA and motivated to grow and excel with the support and direction from an interdisciplinary team of engineers. Join us for a competitive salary, compensatory PTO, and comprehensive benefits. Become part of a supportive work environment that emphasizes team culture, empowering engineers with more responsibility, professional growth and a work-life balance.


Responsibilities and Duties:

Carry out all aspects of a validation project for our Biopharmaceutical clients including: authoring and/or executing Validation Master Plan (VMP), User Requirements Specifications (URS), Risk Assessments (RA), Design Qualification (DQ), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV) protocols/reports in accordance with corporate and departmental procedures.


  • Validation Planning: Develop validation master plans outlining the validation strategy, scope, and timelines for the project.
  • Documentation Management: Oversee the creation, review, and approval of validation protocols, reports, and other documentation required for validation activities.
  • Risk Assessment: Conduct risk assessments to identify potential validation issues and develop mitigation strategies to address them.
  • Protocol Execution: Oversee the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems within the QC building.
  • Commissioning Support: Collaborate with the commissioning team to ensure a seamless transition from construction to operation, verifying that systems and equipment are installed correctly and function as intended.
  • Standard Operating Procedure: Provide technical input with respect to Standard Operating Procedures (SOP) development. Revise or develop SOPs in compliance with industry standards and cGMP.
  • Participate on cross-functional teams to assist with Out of Specification (OOS), Deviation investigation, CAPA and Change Controls write-up.
  • Perform Periodic Review for various validated systems including computerized systems, laboratory equipment, manufacturing equipment, infrastructure systems. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps and corrective actions.
  • Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities.


Qualifications

  • B.S. degree in engineering field or relevant equivalent
  • Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
  • Minimum 5 years of direct work experience in a GMP/pharmaceutical environment, writing and executing commissioning and validation.
  • Excellent knowledge of the Current Good Manufacturing Practices.
  • Ability to work in a team environment with excellent communication skills.
  • Ability to demonstrate a sense of urgency, flexibility and accountability.
  • Flexibility to travel to the client site on a frequent basis.
  • Meticulous attention to detail.
  • Experience in working in cleanrooms and familiar with gowning requirements.


Preferred Qualifications

  • Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA) or Failure Mode and Effect Analysis (FMEA)
  • Experience in Aseptic Processing
  • Familiarity with current industry standards for facilities, utilities, and equipment qualification.
  • Familiarity with Computerized Systems Validation and ISPE GAMP5 and 21 CFR Part 11.
  • Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results.

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