Computer Software Validation Specialist

2 days ago


Canton, Ohio, United States Beacon Hill Life Sciences - Boston Full time
Job Title: Computer Software Validation

We are seeking a highly experienced Computer Software Validation professional to join our team at Beacon Hill Life Sciences - Boston. The ideal candidate will possess a deep understanding of software validation principles and methodologies, with a specific focus on ensuring compliance within regulated environments.

Key Responsibilities:
  1. Software Validation: Execute validation activities for laboratory and analytical software systems, ensuring compliance with regulatory requirements such as FDA, EU GMP, and other relevant standards.
  2. Documentation: Develop and maintain validation documentation including validation plans, protocols, test scripts, and summary reports in alignment with company SOPs and regulatory guidelines.
  3. Risk Management: Conduct risk assessments to identify and mitigate potential software validation risks, ensuring the integrity of data generated by lab and analytical equipment.
  4. Change Control: Manage change control processes related to software validation activities, ensuring that changes are implemented in a controlled and documented manner.
  5. Cross-functional Collaboration: Collaborate closely with cross-functional teams including Quality Assurance, IT, Engineering, and Operations to ensure alignment of validation activities with overall business objectives.
  6. Controlled Temperature Units: Specifically focus on the validation of software systems associated with controlled temperature units, ensuring accuracy and reliability of temperature monitoring and control.
Qualifications:
  • Minimum of 5 years of experience in computer software validation within regulated industries, with a focus on lab and analytical equipment and software.
  • In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
  • Experience with validation tools and methodologies, including IQ/OQ/PQ, CSV risk assessments, and traceability matrices.
  • Strong understanding of controlled temperature units and their integration with software systems.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.



  • Canton, Ohio, United States Beacon Hill Life Sciences - Boston Full time

    Job OverviewWe are seeking a highly experienced Computer Software Validation Specialist to join our team at Beacon Hill Life Sciences - Boston. The ideal candidate will possess a deep understanding of software validation principles and methodologies, with a specific focus on ensuring compliance within regulated environments.Key ResponsibilitiesSoftware...


  • Canton, Ohio, United States Beacon Hill Life Sciences - Boston Full time

    Job OverviewPosition Summary: We are looking for a seasoned Software Validation Specialist with a minimum of 5 years of practical experience in laboratory and analytical software. The ideal candidate will have a comprehensive grasp of software validation techniques and practices, particularly in ensuring adherence to compliance standards in regulated...


  • Canton, Ohio, United States DRB Systems LLC Full time

    Position Overview:Join DRB Systems LLC as an Order Fulfillment Specialist, where you will play a crucial role in our dynamic software organization. This position involves processing orders and managing Return Merchandise Authorizations (RMAs) in a fast-paced environment. About Us:DRB Systems LLC, a subsidiary of Vontier Corporation, is a premier provider of...


  • Canton, Ohio, United States DRB Systems LLC Full time

    Position Overview:Join our dynamic team at DRB Systems LLC as a Customer Order Specialist. We are a thriving software company dedicated to providing innovative solutions for the North American car wash industry. Key Responsibilities:The Customer Order Specialist will serve as a vital link between our customers and our operations team. This role...


  • Canton, Ohio, United States i3 Verticals Healthcare Full time

    Job Title: On-Boarding SpecialistDepartment: i3 Verticals HealthcareJob Location: Canton OH OfficeJob Summary:The On-Boarding Specialist plays a crucial role in our payment processing team, responsible for gathering necessary data and launching the on-boarding process for new merchant accounts. This position requires excellent communication skills, software...

  • Software Developer

    3 days ago


    Canton, Ohio, United States Brechbuhler Scales Full time

    Job Title: Software DeveloperWe are seeking a skilled Software Developer to join our team at Brechbuhler Scales, Inc. in Canton, OH. As a Software Developer, you will be responsible for designing, developing, and implementing software applications for the scale and weighing industry.Key Responsibilities:Develop software applications using C#/.NET...


  • Canton, Ohio, United States Uplux Homes Full time

    Job OverviewWe are seeking an Administrative Support Specialist with a solid background in office operations.Key Responsibilities:Provide reliable and efficient administrative support.Utilize problem-solving skills to address challenges effectively.Demonstrate proficiency in computer applications and essential software.Company Profile:Uplux Homes is a...

  • Software Developer

    9 hours ago


    Canton, Ohio, United States Brechbuhler Scales Inc Full time

    Job SummaryWe are seeking a skilled software developer to join our team at Brechbuhler Scales, Inc. The ideal candidate will have knowledge of C#/.NET framework/JS, Azure, Blazor, and other web development technologies.The software developer will be responsible for developing applications for the scale & weighing industry, as well as maintaining and...


  • Canton, Ohio, United States CommQuest Services Inc Full time

    Job Title: Prior Authorization SpecialistCommQuest Services Inc is seeking a skilled Prior Authorization Specialist to join our team in the Canton/Massillon area.The successful candidate will be responsible for securing prior authorizations for behavioral health services, ensuring compliance with payor guidelines, and reducing denials.Key...

  • Software Engineer

    4 days ago


    Canton, Ohio, United States Brechbuhler Scales Inc Full time

    Job OpportunityWe are seeking a skilled software developer to join our team at Brechbuhler Scales, Inc. in Canton, OH. As a mid-level developer, you will be responsible for designing, developing, and maintaining software applications for the scale and weighing industry.Key Responsibilities:Develop software applications using C#/.NET framework, Azure, and...


  • Canton, Ohio, United States CommQuest Services Inc Full time

    Prior Authorization SpecialistCommQuest Services Inc is seeking a skilled Prior Authorization Specialist to join our team in the Canton/Massillon area.About the RoleThe Prior Authorization Specialist will be responsible for securing prior authorizations for behavioral health services, ensuring that all necessary approvals are obtained from insurance...


  • Canton, Ohio, United States Walsh University Full time

    Job Overview Position Summary Walsh University's Division of Mathematics and Sciences is in search of qualified candidates for a faculty role within its undergraduate Computer Science/Digital Technology/Information Science program. A minimum of a Master's degree in Computer Science or a related field is mandatory. This is a non-tenure track role. ...


  • Canton, Ohio, United States Stark County Education Service Center Full time

    Fiscal Support Specialist InternJoin the Stark County Education Service Center team as a Fiscal Support Specialist Intern and contribute to the success of our educational entities. As a key member of our team, you will provide critical support to our fiscal operations, ensuring the smooth functioning of our financial systems.Key Responsibilities:Fiscal...


  • Canton, Ohio, United States Walsh University Full time

    Job SummaryWalsh University's Division of Mathematics and Sciences is seeking a qualified candidate for a faculty position in its undergraduate Computer Science/Digital Technology/Information Science program.Key ResponsibilitiesTeach 24 credit hours per academic year with appropriate professional scholarshipContribute to the development and restructuring of...


  • Canton, Ohio, United States Walsh University Full time

    Job Details Position Overview Walsh University's Division of Mathematics and Sciences is in search of qualified candidates for a faculty role within its undergraduate Computer Science/Digital Technology/Information Science program. Candidates must possess at least a Master's degree in Computer Science or a related field. This position is classified...


  • Canton, Ohio, United States Walsh University Full time

    Job Overview Position Summary Walsh University's Division of Mathematics and Sciences is actively seeking qualified candidates for a faculty role within its undergraduate Computer Science/Digital Technology/Information Science program. Candidates must possess a minimum of a Master's degree in Computer Science or a closely related field. This position...

  • Software Developer

    5 days ago


    Canton, Ohio, United States Brechbuhler Scales Full time

    Job Title: Software DeveloperWe are seeking a skilled Software Developer to join our team at Brechbuhler Scales, Inc. in Canton, OH.Job SummaryThe ideal candidate will have knowledge of C#/.NET framework/JS, Azure, Blazor, and other web development technologies. They will be responsible for developing applications for the scale & weighing industry, as well...


  • Canton, Ohio, United States i3 Verticals Healthcare Full time

    Job Title: On-Boarding SpecialistJob Summary:The On-Boarding Specialist plays a crucial role in our payment processing team, responsible for gathering necessary data and launching the on-boarding process for new merchant accounts. This position requires excellent communication skills, software support experience, and a customer-centric approach.Key...


  • Canton, Ohio, United States CAIRE Inc. Full time

    Job DescriptionThis is a key software engineering role at CAIRE Inc. that will be responsible for supporting the company's manufacturing operations by managing and supporting all lifecycle phases of various manufacturing software systems.The successful candidate will be responsible for designing, developing, documenting, validating, deploying, monitoring,...


  • Canton, Ohio, United States Walsh University Full time

    Job DetailsDescriptionPosition SummaryWalsh University's Division of Mathematics and Sciences is seeking a qualified candidate for a faculty position in its undergraduate Computer Science program. A Master's degree in Computer Science or a related discipline is required. This is a non-tenure track position.Essential Duties and ResponsibilitiesThe essential...