Facility Validation Engineer

4 weeks ago


New Brunswick, United States Kaztronix LLC Full time

Facilities Validation Engineer

No C2C or sponsorship


The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements.


Job Function:

  • Prepare and execute IQ / OQ / PQ protocols and write summary reports for production/packaging equipment, utilities (Temperature mapping study, Stability Chamber , HVAC, Air compressor, Boiler, Purified water system) and process area etc.,
  • Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP.
  • Prepare and train for the Set up / Operational / Cleaning / Maintenance SOPs
  • Identify, investigate and troubleshoot deviations for multiple concurrent projects
  • Preparation of Personnel flow, Incoming and Finished material flow, as well as Waste flow in the facility
  • Assist in preparation of internal audit, FDA, DEA and other agency audit responses.
  • Prepare, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.


Manufacturing / Production environment

  • Environmental related to manufacturing/production environments:
  • Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
  • Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
  • Odors: Unpleasant smells.
  • Gases: Examples include carbon monoxide and ozone.
  • Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
  • Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.


Education and Experience

  • Minimum of five (5) years in Pharmaceutical, preferably Oral Solid Dosage.
  • Bachelor's Degree in Engineering or Science related field.
  • Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that supports production operations as well as research and development.
  • Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS,VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPs, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan.
  • Technical knowledge to write, prepare and execute the Change Controls, Investigations, SOPs, protocols, final summary reports and validation documents.
  • Demonstrated excellent communication: verbal, written and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • A team building champion driving innovative cross functional synergies.
  • Excellent project management and problem solving skill
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).



  • New Brunswick, United States CareerBuilder Full time

    Facilities Validation Engineer No C2C or sponsorship The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. Job Function: Prepare and execute IQ / OQ / PQ protocols and write summary reports for production/packaging...


  • New Brunswick, United States Kaztronix LLC Full time

    Facilities Validation Engineer No C2C or sponsorshipThe Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. Job Function: Prepare and execute IQ / OQ / PQ protocols and write summary reports for production/packaging...


  • New Brunswick, United States Kaztronix Full time

    Facilities Validation Engineer No C2C or sponsorship The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. Job Function: Prepare and execute IQ / OQ / PQ protocols and write summary reports for production/packaging...


  • New York, United States Trinity Consultants Full time

    ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies. The successful candidate will work with a group of engineers...


  • New York, United States TalentBurst Full time

    Title: Validation Engineer III, Req#: ROCGJP00025890 Location: Oceanside, CA (100% onsite) Duration: 8+ months Contract Job Description: A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. Education and Experience: 5 -7 years of relevant...

  • Validation Engineer

    1 week ago


    New York, United States Premier Life Sciences LLC Full time

    Not For C2C Candidates Please do not apply even not enquire Job Title: CQV Validation Engineer Location: Countrywide USA Contract Duration: 12+ months Pay: Negotiable on w2 without any benefits Responsibilities: Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and...

  • Validation Engineer

    4 days ago


    New York, United States Premier Life Sciences LLC Full time

    Not For C2C Candidates Please do not apply even not enquire Job Title: CQV Validation Engineer Location: Countrywide USA Contract Duration: 12+ months Pay: Negotiable on w2 without any benefits Responsibilities: Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and...

  • Validation Engineer

    2 days ago


    New York, United States Astrix Inc Full time

    Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Validation Engineer to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference! Shift : M-F 1st shift Type : 7...

  • Validation Engineer

    2 weeks ago


    New York, United States Kelly Science, Engineering, Technology & Telecom Full time

    Validation Engineer | Contract-To-Hire Clearwater, FL | On-Site The Validation Engineer is responsible for developing, documenting, and validating manufacturing processes, related to the manufacture, inspection, and packaging of lathed intraocular lenses. Specific tasks to include: new technology and process improvements for existing manufacturing processes,...

  • Validation Engineer

    1 week ago


    New York, United States Premier Life Sciences LLC Full time

    Not For C2C Candidates Please do not apply even not enquire Job Title: CQV Validation Engineer Location: Countrywide USAContract Duration: 12+ monthsPay: Negotiable on w2 without any benefitsResponsibilities:Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and...

  • Validation Engineer

    3 weeks ago


    New Hanover County Airport, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer. This position, in the Manufacturing and Formulations Services department, requires a Bachelor’s degree or higher in a scientific or engineering discipline with either 3...

  • Validation Engineer

    3 weeks ago


    New Hanover County, NC, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer. This position, in the Manufacturing and Formulations Services department, requires a Bachelor’s degree or higher in a scientific or engineering discipline with either 3...

  • Validation Engineer

    2 days ago


    New York, United States PCI Pharma Services Full time

    Summary of Objective: The Validation Engineer is responsible for the qualification/validation of pharmaceutical equipment, processes, and test methods for the assembly, inspection, testing, and packaging of medical devices. Core functions include management of validation projects, generation and execution of validation protocols, evaluation of statistical...


  • New York, United States SciPro Inc. Full time

    Senior Validation Engineer (Contract) Location: Van Nuys Area Role Overview We're seeking a highly skilled Senior Validation Engineer for a temporary onsite role. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documentation and validation tasks for automation projects. You'll also draft design...


  • New York, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. RECRUITERS: DO NOT CONTACT. SUMMARY OF THE JOB As a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing robust validation strategies. Your expertise will be essential in verifying and...

  • Validation Engineer

    1 week ago


    New York, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures,...

  • Validation Engineer

    2 weeks ago


    New York, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures,...


  • New York, United States Teoresi Group Full time

    We are looking for a: Mechanical Development and Validation Engineer The resource will be involved in: Coordinating bench testing with nominated suppliers to fully execute Design Validation Plans activities within the required timeframe Working with testing suppliers for debugging and triage of on-going test issues (at the plant or on the...


  • New Albany, United States Validation & Engineering Group Full time

    Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a...


  • New York, United States BioPhase Full time

    *US Citizens or Greencard Holders only* **No C2C** Work Schedule: Onsite - M-F Salary: $60-70/hr Duration: 4 months Primary Responsibilities: Support the Quality Engineering group with documentation and validation needs. Draft URS documents, design specifications, testing protocols, and final reports. Perform hands on validation execution for automation...