Validation Lifecycle Manager

3 weeks ago


Durham, North Carolina, United States KBI BioPharma Full time
About the Role">

We are seeking a talented Validation Lifecycle Manager to join our team at KBI BioPharma. As a Validation Lifecycle Manager, you will be responsible for managing the validation lifecycle process and ensuring the qualification of equipment and systems.


Key Responsibilities:">
  • Manage the validation lifecycle process, ensuring all equipment and systems are in a qualified state suitable for intended use.
  • Develop and execute life cycle engineering and validation lifecycle documentation elements in accordance with regulatory requirements.
  • Maintain and access the validation documentation archive to fulfill internal/external client and/or auditor requests.
  • Coordinate validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.

Qualifications:">
  • Bachelor's degree in Chemical Engineering, Industrial Engineering, or related scientific field.
  • Three to five years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in the pharmaceutical/biotechnology industries.
  • Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
  • Technical writing and literacy in engineering documentation review/interpretation.

Compensation and Benefits:">

The salary range for this position is $70,156 - $96,465 per year. KBI BioPharma offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.



  • Durham, North Carolina, United States Unique Hardware Software Systems Company in Major Growth Mode Full time

    Product Lifecycle Management ProfessionalWe are seeking an experienced Product Lifecycle Management (PLM) Professional to join our team at Unique Hardware Software Systems Company. This exciting opportunity offers a competitive salary of $160,000 - $220,000 per year, plus benefits and bonuses.The ideal candidate will have a strong background in Electrical...


  • Durham, North Carolina, United States FUJIFILM Corporation Full time

    Job SummaryFUJIFILM Diosynth Biotechnologies is seeking a Quality Assurance Operations Engineer to drive quality oversight for all Drug Substance Manufacturing processes through to operational readiness during project phase.About the CompanyWe are a Contract Development & Manufacturing Organization (CDMO) that partners with clients to deliver recombinant...


  • Durham, North Carolina, United States NavitsPartners Full time

    About the JobNavitsPartners is a leading company in the industry, and we are looking for a highly skilled Validation and Calibration Expert to join our team. As a key member of our team, you will be responsible for providing validation support for equipment calibration documentation and ensuring compliance with corporate and industry standards.The estimated...


  • Durham, North Carolina, United States PSC Biotech Full time

    About PSC BiotechPSC Biotech delivers high-quality services to the life sciences industry, focusing on regulatory compliance and client satisfaction. We aim to provide a supportive work environment that fosters professional growth and development.Job Description:This position requires an experienced Validation Project Manager with expertise in...


  • Durham, North Carolina, United States PSC Biotech Full time

    About PSC BiotechPSC Biotech provides essential services to the life sciences industry, ensuring compliance with regulatory requirements. Our goal is to support clients' success by employing skilled professionals and experts worldwide.Job Description:We are seeking an experienced Validation Project Manager to join our team. The successful candidate will have...


  • Durham, North Carolina, United States Valspec Full time

    About the JobValspec is a leading provider of system validation and lifecycle services, specializing in commissioning and qualification of computerized systems for clients in the Life Sciences industry. With over 20 years of experience, our mission is to deliver high-quality services that meet our clients' capital project and lifecycle maintenance goals.The...

  • Validation Specialist

    4 hours ago


    Durham, North Carolina, United States Arcadis Full time

    About the RoleArcadis is seeking an experienced CQV Engineer to join our team. This individual will be responsible for ensuring that QC lab analytical equipment meets cGMP requirements.The ideal candidate will have experience in performing CQV activities for QC Lab and analytical equipment. They will also possess excellent communication skills, both written...


  • Durham, North Carolina, United States IQVIA Full time

    Your Qualifications:To be successful in this role, you will need:Associate's Degree in electronics or mechanical technology or a closely related field.Hands-on experience in calibration and repair of measuring and test equipment.Proficiency with Windows, Microsoft Office, and Word, with an emphasis on Excel.Experience in troubleshooting laboratory equipment...


  • Durham, North Carolina, United States Mastech Digital Full time

    Cleaning Validation EngineerOur company is seeking an experienced Cleaning Validation Engineer to manage and coordinate engineering activities regarding CIP (Cleaning In Place) and SIP (Sterilization In Place).Key Responsibilities:Management of CIP/SIP design and validationDevelopment of CIP/SIP strategiesReview of user requirements for CIP/SIPCoordination...


  • Durham, North Carolina, United States bioMerieux Inc. Full time

    Key Responsibilities: As a Validation Engineer at bioMerieux Inc., your key responsibilities will include: Executing assigned validation projects with guidance and support from project validation lead/manager. Employing robust validation principles and practices to ensure project requirements, risk mitigation, and project timelines are achieved. Working...


  • Durham, North Carolina, United States Intellectt Inc Full time

    About the Role:We are seeking a highly skilled Data Validation Specialist to join our team at Intellectt Inc. In this role, you will be responsible for validating MODA ES or similar systems in the pharmaceutical industry.Your primary focus will be on creating and updating SOPs, trainings, and validation documentation associated with life cycle management,...


  • Durham, North Carolina, United States Intellectt Inc Full time

    About the RoleWe are looking for a talented individual with extensive experience in validating MODA ES or similar systems in the pharmaceutical industry. Your primary responsibility will be to create, update, and maintain SOPs, trainings, and validation documentation associated with life cycle management approaches.

  • Validation Specialist

    9 hours ago


    Durham, North Carolina, United States Arcadis Full time

    Job SummaryThe successful candidate will be responsible for executing and managing QC lab analytical equipment activities to meet cGMP requirements.This includes initiating equipment validation protocol development, drafting documents, managing review cycles, and obtaining approval.


  • Durham, North Carolina, United States Aspida Financial Services LLC Full time

    About the OpportunityWe are seeking an Annuity Validation Expert to join our team at Aspida Financial Services LLC. In this role, you will be responsible for developing and maintaining annuity product calculation engines, ensuring the accuracy and reliability of our products.You will work closely with cross-functional teams to create and improve product...


  • Durham, North Carolina, United States Strata Solar LLC Full time

    Job Summary:Strata Solar LLC is seeking a highly skilled Contract Management Director to lead our contract operations team and oversee the entire contract lifecycle, from creation to closeout. This role requires strong leadership and management skills, as well as expertise in contract management tools and software.About Us:Strata Solar LLC is a leading...


  • Durham, North Carolina, United States Strata Solar LLC Full time

    About the RoleAs a Senior Contract Manager at Strata Solar LLC, you will play a critical role in leading the company's contract operations team and ensuring the efficient and effective management of contracts.You will be responsible for defining and standardizing the contracting process for the company, as well as facilitating activities with the deployment...


  • Durham, North Carolina, United States aqualis Full time

    Aqualis is a nationwide leader in comprehensive water management services, focusing on maintaining, inspecting, and repairing post-construction stormwater and lift station systems. Our team provides environmental compliance while inspiring change by preserving and protecting our most precious natural resource-water.We deliver sustainable water management to...


  • Durham, North Carolina, United States RCM Technologies, Inc. Full time

    Responsibilities:Create/update documentation associated with life cycle management approaches, traceability, end-to-end testing, data process maps, and periodic reviews to ensure compliance with regulatory standards.Author and execute validation documentation for functional specifications, interfaces, upstream/downstream units, and batch reports to guarantee...


  • Durham, North Carolina, United States NavitsPartners Full time

    Job DescriptionAt NavitsPartners, we are seeking a highly skilled Quality Assurance Specialist to support our validation activities throughout the product lifecycle. As a key member of our team, you will be responsible for providing validation support for equipment calibration documentation and ensuring compliance with corporate and industry standards.The...


  • Durham, North Carolina, United States Strata Clean Energy Full time

    Job Description: Lead Contracts ManagerStrata Clean Energy seeks a highly experienced Lead Contracts Manager to oversee the entire contract lifecycle, from creation to closeout. The successful candidate will lead the contract operations team, ensuring efficient and effective contract management processes. Key responsibilities include negotiating and...