Senior Validation Engineer

3 weeks ago

Parsippany, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision.
  • Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities.
  • Cleaning Verification / Validation studies for transferred products.
  • Media Fills / process simulations protocols.
  • Engineering protocols to support packaging validation / shipping study activities.
  • Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances.
  • ssist in execution of Process Validation and Engineering studies.
  • Review commissioning, qualification, validation projects performed by Validation Specialists and / or Validation contractors.
  • Generate Validation Master Plans (VMPs) and Risk Assessments related to large level qualification projects.
  • Monitor and track protocol and report status.
  • Complete GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists, and final handover of documents to Operations with minimal supervision.
  • Mentor and train junior level Validation Specialists on various validation tasks.
  • Plan and complete commissioning, qualification, and validation activities performed in facility.
  • Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.
  • Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies.
  • Participate and able to answer questions during intern and external audits, as needed.
  • Close change controls, CAPAs, and investigations, as well as ensure deviations, CAPAs, and change controls issued to the department(s) are tracked (closed on time, or extended if necessary.)
  • Prepares Final Reports summarizing the results of executed Validation / Qualification studies and address comments and questions from reviewers / approvers.
  • ssist Production, Engineering, and/ or IT in improving / optimizing performance of process / packaging equipment.
  • Update yearly Validation Master Plan.
Requirements:
  • Bachelor's degree in engineering or related field, or equivalent combination of education and work-related experience, required.
  • Minimum 5 years of hands-on experience in validation (PV, CV), specifically within the pharmaceutical sector.
  • Subject matter expert in at least two (2) of the Qualification / Validation subjects specified below
  • Sterile Process Equipment Qualification
  • Packaging Equipment Qualification
  • Media Fills
  • Utilities Commissioning / Qualification
  • Cleaning Verification / Validation
  • Process Validation
  • QC Equipment Qualification
  • Computer System Validation
  • Environmental Monitoring Qualification of Classified Areas
  • Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements
  • Proficiency in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Excellent problem-solving and analytical skills.
  • Strong communication and teamwork abilities.
  • bility to work independently in a timely manner.

  • Validation Engineer

    1 week ago

    Parsippany, United States Insight Global Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Engineer

    5 days ago

    Parsippany, United States Insight Global Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Engineer

    7 days ago

    Parsippany, United States Insight Global Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Engineer

    1 week ago

    Parsippany, United States Insight Global Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Engineer

    1 week ago

    Parsippany, United States Insight Global Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Specialist

    2 days ago

    Parsippany, United States Ferring Pharmaceuticals Inc. Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Specialist

    4 weeks ago

    Parsippany, United States Ferring Pharmaceuticals Full time

    Day to Day:Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Specialist

    4 weeks ago

    Parsippany, United States Ferring Pharmaceuticals Full time

    Day to Day:Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Specialist

    3 weeks ago

    Parsippany, United States Ferring Pharmaceuticals Inc. Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Validation Specialist

    2 weeks ago

    Parsippany, United States Ferring Pharmaceuticals Inc. Full time

    Day to Day: Make your application after reading the following skill and qualification requirements for this position. Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial...

  • Validation Engineer

    1 week ago

    Parsippany-Troy Hills, United States Insight Global Full time

    Day to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...

  • Senior Engineer V

    1 day ago

    Parsippany, United States CHA Consulting, Inc. Full time

    WHY CHA?: Finding a better way. At CHA, we believe in the power of clean water, resilient energy, safer roads, and structures that harmoniously blend with their surroundings. We create solutions. We help People. We improve our world. At CHA, we embed ourselves in our communities - and take pride in improving things where we live. At the foundation is a...

  • Senior Mechanical Engineer

    1 day ago

    Parsippany, United States CHA Consulting, Inc. Full time

    WHY CHA?: Finding a better way. At CHA, we believe in the power of clean water, resilient energy, safer roads, and structures that harmoniously blend with their surroundings. We create solutions. We help People. We improve our world. At CHA, we embed ourselves in our communities - and take pride in improving things where we live. At the foundation is a...

  • Senior Mechanical Engineer

    2 days ago

    Parsippany, United States CHA Consulting, Inc. Full time

    WHY CHA? Finding a better way. At CHA, we believe in the power of clean water, resilient energy, safer roads, and structures that harmoniously blend with their surroundings. We create solutions. We help People. We improve our world. At CHA, we embed ourselves in our communities - and take pride in improving things where we live. At the foundation is a...

  • Senior Mechanical Engineer

    14 hours ago

    Parsippany, United States CHA Consulting, Inc. Full time

    WHY CHA? Finding a better way. At CHA, we believe in the power of clean water, resilient energy, safer roads, and structures that harmoniously blend with their surroundings. We create solutions. We help People. We improve our world. At CHA, we embed ourselves in our communities - and take pride in improving things where we live. At the foundation is a...

  • Senior Environmental/Civil Engineer

    1 day ago

    Parsippany, United States Dewberry Full time

    Job Description: Dewberry is currently seeking a Senior Environmental/Civil Engineer for our Parsippany, NJ office. The position will perform a variety of environmental engineering tasks in support of navigation channel maintenance dredging operations including beneficial use, coastal restoration, stormwater management, resiliency planning, and environmental...

  • Senior Environmental/Civil Engineer

    15 hours ago

    Parsippany, United States Dewberry Full time

    Job Description: Dewberry is currently seeking a Senior Environmental/Civil Engineer for our Parsippany, NJ office. The position will perform a variety of environmental engineering tasks in support of navigation channel maintenance dredging operations including beneficial use, coastal restoration, stormwater management, resiliency planning, and environmental...

  • Senior DevOps Engineer

    1 week ago

    Parsippany, United States Spyglass Partners, LLC Full time

    Senior DevOps EngineerHybrid model - onsite in the Parsippany, NJ area. 5 - 8+ years of experience as DevOps Engineer. Experience in DevOps tools – Azure DevOps/GitHub Action. Proficiency with CI/CD tools and Azure DevOps tooling and deployment automation best practices.Experience with Git and Git flowsExperience with IaC – Terraform/ARM/Cloud...

  • Senior DevOps Engineer

    1 week ago

    Parsippany, United States Spyglass Partners, LLC Full time

    Senior DevOps EngineerHybrid model - onsite in the Parsippany, NJ area. 5 - 8+ years of experience as DevOps Engineer. Experience in DevOps tools – Azure DevOps/GitHub Action. Proficiency with CI/CD tools and Azure DevOps tooling and deployment automation best practices.Experience with Git and Git flowsExperience with IaC – Terraform/ARM/Cloud...

  • Senior Electrical Engineer

    5 days ago

    Parsippany, United States GCR Technical Staffing Full time

    Job Description Job Description Senior Electrical Engineer Description: Sr Electrical Engineer will work on schematic design and analysis and assist with placement of routing in boards and documentation of boards. Heavily involved in the release process of documents They need to work well with systems and test and software and mechanical engineering...