Validation Specialist

4 weeks ago

Saddle Brook, United States Lynkx Staffing LLC Full time
Job DescriptionJob DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc.
  • Execute IQ/OQ and /or PQ protocols
  • Prepare final reports for executed protocols
  • Prepare final reports for vendor IQ, OQ and/or PQ protocols
  • Review of executed IQ/OQ/PQ protocols and raw data
  • Perform periodic review/requalification of validated equipment, systems and cleanrooms
  • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met
  • Assembling validation related documents; and filing/archiving approved documents
  • Maintaining electronic records.
REQUIREMENTS
  • BS/BA in engineering or a related Science discipline
  • 3-7 + years of validation experience
  • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc.
  • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11.
  • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary.
  • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management.
  • Must be a dedicated self-starter with a high energy level and able to achieve results.
  • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution.
  • Good time management skills to manage and meet deadlines.
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment.
  • Good computer skills and Microsoft Office knowledge.
  • Ability to multi-task team is essential.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Highly organized, detail oriented, and ability to manage multiple priorities.
  • Ability to perform the job under direct or indirect supervision
  • Must have the ability to work in a team-oriented environment and with clients
  • Must have the ability to work with specialized equipment
May occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

  • Validation Specialist

    2 months ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and...

  • Quality Assurance Compliance Specialist

    2 months ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance...

  • Major Account Executive

    4 weeks ago

    Saddle Brook, United States Konica Minolta Full time

    Overview Konica Minolta currently has an exciting opportunity for you to join us as a  Major Account Executive - Government & Education Specialist!  Responsibilities You will seek out new customers and partner with existing ones by offering a variety of solutions to improve their business and take exceptional care of your clients. You will...

  • Senior Technology Sales Representative

    3 weeks ago

    Saddle Brook, United States Konica Minolta Business Solutions, U.S.A., Inc. Full time

    Overview:At Konica Minolta, we partner with our customers to design Future of Work technology solutions to help their business thrive. From process automation, cyber security, advanced printer technology, managed IT services, video security systems and more, we add value by tailoring our solutions to enhance our customer’s success.As a Senior Technology...

  • Major Account Executive

    3 weeks ago

    Saddle Brook, United States Konica Minolta Business Solutions, U.S.A., Inc. Full time

    Overview: Konica Minolta currently has an exciting opportunity for you to join us as a **Major Account Executive - Government & Education Specialist!** **Responsibilities**: - You will seek out new customers and partner with existing ones by offering a variety of solutions to improve their business and take exceptional care of your clients. - You will...

  • Major Account Executive

    1 month ago

    Saddle Brook, United States Konica Minolta Business Solutions Ltd Full time

    Job Description OverviewKonica Minolta currently has an exciting opportunity for you to join us as a Major Account Executive - Government & Education Specialist! ResponsibilitiesYou will seek out new customers and partner with existing ones by offering a variety of solutions to improve their business and take exceptional care of your clients. You will...

  • Major Account Executive

    4 weeks ago

    Saddle Brook, United States Konica Minolta Business Solutions Ltd Full time

    Job Description OverviewKonica Minolta currently has an exciting opportunity for you to join us as a Major Account Executive - Government & Education Specialist! ResponsibilitiesYou will seek out new customers and partner with existing ones by offering a variety of solutions to improve their business and take exceptional care of your clients. You will...

  • Billing Specialist

    7 days ago

    Oak Brook, United States Long Iron Services, LLC Full time

    It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. Heniff Transportation provides best-in-class supply chain solutions to our valued customers by utilizing our network of supply chain services and resources. We focus on creating extraordinary growth and...

  • Billing Specialist

    5 days ago

    Oak Brook, United States Long Iron Services, LLC Full time

    It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. Heniff Transportation provides best-in-class supply chain solutions to our valued customers by utilizing our network of supply chain services and resources. We focus on creating extraordinary growth and...

  • Intelligence Specialist

    2 weeks ago

    Stony Brook, United States Stony Brook University Full time

    **Intelligence Specialist** **Required Qualifications (as evidenced by an attached resume)**: Bachelor’s degree (foreign equivalent or higher) in Criminal Justice, Psychology, Homeland Security, Intelligence Analysis or a related field. Three (3) years of full-time demonstrated ability to analyze data and produce intelligence reports (student experience...

  • Materials Specialist

    4 weeks ago

    Honey Brook, United States R-V Industries, Inc. Full time

    R-V Industries has a day shift opening for a Materials Specialist! This is a Monday to Thursday position, 6am to 4pm. Previous experience rigging and using over head cranes in a metal manufacturing shop is preferred! **At R-V Industries, our work is much more than designing and building world-class industrial process equipment. Not only are we impacting...

  • Environmental Specialist

    1 week ago

    Oak Brook, Illinois, United States GZA GeoEnvironmental Full time

    Huff & Huff, Inc. a subsidiary of GZA (H&H/GZA) is currently seeking Environmental Specialist from two to eight years' experience to support our environmental natural resources practice. This role will be a hybrid position working on a project site in Springfield, Illinois. The successful candidates will have a solid educational background and must be...

  • Environmental Specialist

    2 weeks ago

    Oak Brook, United States GZA GeoEnvironmental Full time

    Huff & Huff, Inc. a subsidiary of GZA (H&H/GZA) is currently seeking Environmental Specialist from two to eight years' experience to support our environmental natural resources practice. This role will be a hybrid position working on a project site in Springfield, Illinois. The successful candidates will have a solid educational background and must be...

  • Accounts Payable Specialist

    5 days ago

    Oak Brook, United States Hub Group Full time

    **Job Summary**: The Accounts Payable Specialist is responsible for preparation, entering and managing invoices review, validation, entry, approval and exception processing. **Essential Job Functions**: - Index incoming Expense reports and receipts. Index and enter non trade general expenses and claims. - Data entry, as well as creating, updating data. -...

  • Senior Compensation Specialist

    2 weeks ago

    Oak Brook, United States Heniff Company Full time

    Senior Compensation Specialist page is loaded Senior Compensation Specialist Apply locations IL, Oak Brook time type Full time posted on Posted 30+ Days Ago job requisition id JR100151 It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. The Senior Compensation...

  • Sampling Program Specialist

    1 week ago

    Stony Brook, United States Stony Brook University Full time

    **Sampling Program Specialist** **Required Qualifications: (as evidenced by an attached resume)** Bachelor's degree (foreign equivalent or higher) in-hand date by appointment date. Two (2) professional full-time years of related experience. Advanced Excel experience (ie.pivot tables, formulas, etc). Experience reading and/or writing technical reports. A...

  • Child Welfare Specialist

    2 weeks ago

    Oak Brook, United States Lutheran Child and Family Services of Illinois Full time

    **Lutheran Child and Family Services of Illinois**: **What We Do**: Lutheran Child and Family Services of Illinois improves the well-being of people across the state by protecting children, strengthening families and building futures for those who have experienced trauma. We do this as a leading provider of a variety of child welfare services. LCFS is a...

  • Accounts Payable Specialist

    2 days ago

    Oak Brook, United States Hub Group Full time

    **Job Summary**: The Accounts Payable Specialist is responsible for preparation, entering and managing invoices review, validation, entry, approval and exception processing. **Major Job Responsibilties**: - Index incoming Expense reports and receipts - Index and enter non trade general expenses and claims - Data entry, as well as creating, updating data -...

  • Senior Compensation Specialist

    2 weeks ago

    Oak Brook, Illinois, United States TalentCount Full time

    At TalentCount we believe Human Resources is the engine that influences the workforce towards success and a positive company culture creates the rhythm to any business. We take pride in hiring the most authenticated, high-EQ human resources and leadership professionals to influence company culture, objectives, and growth.We are currently seeking a Senior...