Junior Validation Engineer

3 weeks ago

Hauppauge, New York, United States Contract Pharmacal Full time
Job Summary:

The Junior Validation Engineer will be responsible for performing process validation, cleaning validation, and equipment validation activities for solid dosage pharmaceuticals. This role requires a strong understanding of US FDA Good Manufacturing Practices (21 CFR) and excellent technical writing skills.

Key Responsibilities:

Create and/or approve validation documents to support manufacturing, packaging, and cleaning validation requirements.

Train operations and quality teams on validation protocols as needed.

Collect validation samples and deliver to appropriate laboratory area/personnel for testing.

Perform review of the executed protocol, validation batch records, test reports for accuracy and Good Documentation Practices.

Compile validation data, perform trend analysis, and develop validation summary report.

Develop and coordinate approval of validation risk assessment memo.

Maintain and periodically update master database with validation activities and the equipment qualification list in Electronic Document Management system.

Assist with change controls, by carrying out investigations for process deviations and corrective actions as needed.

Provide necessary support to operations and quality teams during the execution of process and cleaning validation activities.

Develop and execute equipment qualification protocols (IQ/QO/PQ) and generate qualification summary report, if required.

Maintain the annual calibration program for critical process instruments (temperature controllers, pressure gauges, data loggers, etc.) and work with external vendors to ensure timely completion of calibration activities, if required.

Maintain the annual program and record keeping of documentation for compressed air testing, clean room certifications, HEPA filter testing, if required.

Assist in assessment for gap analysis, modifications, and process enhancements to improve efficiency and quality.

Coordinate with other departments, as needed, for engineering and validation projects.

Other responsibilities as assigned by Senior Management.

Requirements:

Bachelor's degree in engineering or related field.

Master's degree in engineering or related field.

Minimum 2 years work experience in Pharmaceutical, Food, or Cosmetic manufacturing industry in lieu of Master's degree.

Experience with pharmaceutical manufacturing and packaging equipment/process.

Skills, Knowledge, and Abilities:

Excellent oral and written communications skills.

Knowledge of US FDA Good Manufacturing Practices (21 CFR).

Strong technical writing skills.

Ability to prioritize and multitask in a fast-paced environment.

Ability to interact with all levels of personnel.

Physical Demands:

Required to use hands to operate computer controls.

Specific vision abilities required include close vision, ability to focus.

While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, stand, bend, sit, talk, hear, or walk for long periods.

The employee may lift and/or move up to 50 lbs.

Work Environment:

Work environment in production operations facilities include proximity to heavy machinery and pharmaceutical powders.

Potential to move between production operations sites/areas to complete job functions.

Hours/Travel may be subject to change based on management/company discretion.

Supervisory Responsibilities:

None

Pay Range:
$60,000 - $75,000 per year

  • Electrical Design Engineer

    3 weeks ago

    Hauppauge, New York, United States Hepco Full time

    We are seeking a highly motivated Senior Electrical Engineer with 7 to 10 years of experience in the commercial and industrial construction industry to support a growing list of projects in the New York Metropolitan Area.The ideal candidate will have an in-depth knowledge of power system design and a solid foundation in electrical engineering.Key...

  • Senior Electrical Engineer

    3 weeks ago

    Hauppauge, New York, United States Hepco Full time

    We are seeking a highly motivated Senior Electrical Engineer with 7 to 10 years of experience in the commercial and industrial construction industry to support a growing list of projects in the New York Metropolitan Area.The ideal candidate will have an in-depth knowledge of power system design and a solid foundation in electrical engineering.Key...

  • Electrical Engineering Project Manager

    3 weeks ago

    Hauppauge, New York, United States Hepco Full time

    We are seeking a highly skilled Senior Electrical Engineer to support our growing list of projects in the New York Metropolitan Area.The ideal candidate will have a deep understanding of power system design and a strong foundation in electrical engineering.Key responsibilities include collaborating with the team to create construction documents, performing...

  • Mechanical Design Engineer

    4 weeks ago

    Hauppauge, New York, United States FRONTGRADE TECHNOLOGIES Full time

    About UsFrontgrade Technologies is a leading provider of high-reliability and radiation-assured solutions for defense, space, intelligence, commercial, and civil applications. Our products are designed to perform in the harshest of environments, and our team stays in lockstep with our customers to ensure the success of their missions.Why Work for UsWe take...

  • Metal and Glass Engineering Specialist

    3 weeks ago

    Hauppauge, New York, United States Champion Metal & Glass, Inc. Full time

    Job Overview:We are seeking a highly skilled and experienced Engineering professional to join our dynamic team at Champion Metal & Glass, Inc. The ideal candidate will have a strong background in architectural metal and glass engineering. This is a challenging and rewarding role that requires a deep understanding of system design and the ability to work...

  • Mechanical Engineer III

    4 weeks ago

    Hauppauge, New York, United States FRONTGRADE TECHNOLOGIES Full time

    About UsFrontgrade Technologies has been a leading provider of high-reliability and radiation-assured solutions for over six decades. Our team of skilled thinkers, makers, and doers has a proven track record of solving complex technology challenges across the globe.Our MissionWe strive to deliver innovative solutions that meet the needs of our customers. Our...

  • Lead Microwave Assembly Engineer

    4 weeks ago

    Hauppauge, New York, United States NARDA-MITEQ Full time

    Job SummaryNarda-MITEQ is seeking a highly skilled Lead, Integrated Microwave Assembly Engineer to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and testing advanced microwave assemblies and systems.Key ResponsibilitiesDesign and develop complex microwave assemblies and systems using advanced...

  • Mechanical Design Engineer

    3 weeks ago

    Hauppauge, New York, United States FRONTGRADE TECHNOLOGIES Full time

    About Us:At Frontgrade Technologies, we're a team of skilled thinkers, makers, and doers who have been solving complex technology challenges for over six decades. Our mission is to provide innovative solutions for defense, space, intelligence, commercial, and civil applications.We're the leading provider of high-reliability and radiation-assured solutions,...

  • Mechanical Design Engineer

    4 weeks ago

    Hauppauge, New York, United States FRONTGRADE TECHNOLOGIES Full time

    About UsAt Frontgrade Technologies, we've been pushing the boundaries of technology for over six decades. Our team of skilled thinkers, makers, and doers is dedicated to solving complex challenges across the globe.We're the leading provider of high-reliability and radiation-assured solutions for defense, space, intelligence, commercial, and civil...

  • Senior Software Engineer

    4 weeks ago

    Hauppauge, New York, United States Microchip Technology Full time

    We are seeking a highly skilled Principal Engineer-Validation to join our team at Microchip Technology, Inc.This is a unique opportunity to work on advanced connectivity devices, including Ethernet switches, USB 3.2 hubs, PCI-Express, and other connectivity interfaces in excess of 25Gbps.The successful candidate will be a leader in the USB and Networking...

  • Senior Software Engineer

    3 weeks ago

    Hauppauge, New York, United States Microchip Technology Full time

    We are seeking a highly skilled Principal Engineer-Validation to join our team at Microchip Technology, Inc.This role will be a leader in the USB and Networking Validation Team, focused on bringing advanced connectivity devices to market, including Ethernet switches, USB 3.2 hubs, PCI-Express, and other connectivity interfaces in excess of 25Gbps.The ideal...

  • Senior Structural Engineer

    4 weeks ago

    Hauppauge, New York, United States Stantec Full time

    Senior Structural EngineerAt Stantec, we're on a mission to become the world's leading integrated design practice. Our team of Structural Engineers, architects, engineers, interior designers, sustainability specialists, and technologists are passionate about the power of design. We take an innovative, collaborative approach to projects, sharing a common...

  • Senior Network Architect

    3 weeks ago

    Hauppauge, New York, United States Presidio Full time

    About the Role:We are seeking a highly skilled Senior Network Engineer to join our team at Presidio. As a Senior Network Engineer, you will be responsible for leading small to large projects on your own or as part of a team, including planning, design, and implementation of complex network and security engagements.Key Responsibilities:Perform project-based...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Hauppauge, New York, United States CIRCOR Full time

    Job SummaryThe Senior Quality Engineer will lead process capability improvement, working closely with Manufacturing, Materials, and Engineering teams to ensure internal processes are capable of providing products to satisfy customer requirements. The QE will provide focused support for daily production activities and provide guidance for technical data...

  • Manufacturing Engineering Manager

    4 weeks ago

    Hauppauge, New York, United States CIRCOR Full time

    Job SummaryThe Manufacturing Engineering Manager will lead and support the manufacturing engineering team in managing new product introduction, root cause corrective action, process improvement, and identifying necessary equipment and processes to produce quality products and support growth.Key ResponsibilitiesProvide leadership for the day-to-day direction...

  • Manufacturing Engineering Manager

    4 weeks ago

    Hauppauge, New York, United States CIRCOR Full time

    Job Title: Manufacturing Engineering ManagerJoin CIRCOR Aerospace, a leading provider of highly engineered technology, service, and system solutions to the aerospace and associated markets.Job Summary:The Manufacturing Engineering Manager will lead and support the manufacturing engineering team in managing new product introduction, root cause corrective...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Hauppauge, New York, United States Circor Full time

    Job SummaryThe Senior Quality Assurance Engineer will lead process capability improvement, working closely with Manufacturing, Materials, and Engineering teams to ensure internal processes are capable of providing products to satisfy customer requirements. The QE will provide focused support for daily production activities and provide guidance for technical...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Hauppauge, New York, United States CIRCOR International Full time

    Job DescriptionAt CIRCOR International, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality department, you will be responsible for leading process capability improvement initiatives, working closely with manufacturing, materials, and engineering teams to ensure internal processes meet customer...

  • Manufacturing Engineering Manager

    3 weeks ago

    Hauppauge, New York, United States CIRCOR International, Inc. Full time

    Job SummaryCIRCOR International, Inc. is seeking an experienced Manufacturing Engineering Manager to lead our manufacturing engineering team. In this role, you will manage a team of 4-5 engineers focused on new product introduction, root cause analysis, process improvement, and identifying the necessary equipment and processes to ensure high-quality...

  • Manufacturing Engineering Manager

    4 weeks ago

    Hauppauge, New York, United States CIRCOR International, Inc. Full time

    Job Title: Manufacturing Engineering ManagerWe are seeking an experienced Manufacturing Engineering Manager to lead our manufacturing engineering team. In this role, you will manage a team of 4-5 engineers focused on new product introduction, root cause analysis, process improvement, and identifying the necessary equipment and processes to ensure...