Validation Specialist for Computer Systems and Software

7 days ago


Spring Lake, Michigan, United States Northern Biomedical Research Inc Full time
Job Overview

We are seeking a skilled Validation Specialist to coordinate validation efforts for computer systems, hardware, and software in our lab setting. This role is responsible for ensuring process quality and compliance with GxP, GAMP, and Code of Federal Regulations.

Estimated Salary: $95,000 - $120,000 per year

About the Job
  • This salaried position involves managing computer validation project activities, creating planning documents and testing protocols, and reviewing test results to identify areas for improvement.
  • The successful candidate will provide technical expertise to team members and other departments while communicating the validation plan and creating protocols.
Key Responsibilities
  1. Work with QA management to develop and implement an efficient software/computer validation program for a GLP environment.
  2. Identify computerized systems validation needs through in-house assessments or by coordinating needs assessments with external teams.
  3. Partner with business and validation teams for site computer validation projects.
  4. Develop software/validation protocols and final reports, as well as coordinate and perform activities per protocols.
  5. Maintain the site Master Validation Schedule and periodically review validated systems.
  6. Assist QA in auditing vendors of cGMP-related software and hardware.
  7. Evaluate vendor validations and add company-specific protocols as required to complete validation.
  8. Provide technical counsel on issues and concerns regarding validation plans and protocol designs.
  9. Train company staff as needed on SOPs.
Requirements
  • Bachelor's degree or equivalent.
  • 5-10 years of experience in Computer System Validations.
  • Knowledge of GxP.
  • Advanced understanding of laboratory operations and data collection.
  • Ability to work effectively under time constraints.
Working Conditions

This role involves approximately 80% office work and 20% laboratory work, exposing you to animal pathogens and chemicals. You will need to don personal protective gear, including N95 masks and respirators, and have the ability to lift and carry up to 50lbs. Occasional ladder and stair use may be required.



  • Spring Lake, Michigan, United States Northern Biomedical Research Inc Full time

    Northern Biomedical Research Inc is currently seeking a skilled Laboratory Animal Care Specialist to join our team.As a Laboratory Animal Care Specialist, you will be responsible for providing high-quality animal care and support in our laboratory setting. This role involves working with various animal species, collecting and recording data, performing...


  • Lake Orion, Michigan, United States Malace HR Full time

    Job OverviewMalace HR is seeking an experienced Diesel Generator Technician to work onsite at an automotive manufacturer in a strategic location. The position comes with comprehensive benefits package. Qualified Candidates will possess the below skills and qualifications.Key ResponsibilitiesThe Generator Technician is responsible for accurately...


  • Spring Lake, Michigan, United States Northern Biomedical Research Inc Full time

    Job Title:Medical Laboratory SpecialistAbout the Role:We are seeking a highly skilled Medical Laboratory Specialist to join our team at Northern Biomedical Research Inc. The successful candidate will engage in pre-analytical sample processing, maintaining inventory, data collection, and review while supporting the larger Clinical Pathology team in completing...


  • Spring Lake, Michigan, United States Cooper Standard Full time

    About Cooper StandardWe are a leading global supplier of innovative materials and systems to the automotive industry. Our diverse workforce is committed to providing equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, genetic information, physical or mental disability, age, veteran or...


  • Lake Angelus, Michigan, United States Jobot Full time

    Job DescriptionAs a key member of our team at Jobot, we are seeking a highly skilled and experienced Permanent Regional Industrial Safety Specialist to join our dynamic operations in the Manufacturing industry.ResponsibilitiesSafety System Development: Develop and implement safety systems and procedures to ensure the safety of employees and compliance with...


  • Spring Lake, Michigan, United States Soliant Full time

    We are seeking an exceptional Educational Specialist to join our team at Soliant. As a Special Education Teacher, you will play a vital role in providing high-quality instruction and support to students with disabilities.Role OverviewDevelop and implement individualized education plans (IEPs) for students with disabilities, collaborating with...


  • Spring Lake, Michigan, United States Acemco Full time

    About UsAt ACEMCO, we are a leading metal stamping manufacturer with a rich history in Spring Lake, Michigan since 1946. We are committed to providing exciting opportunities for our employees to develop professionally and grow with our company.Job SummaryWe are seeking a highly skilled Residential Sanitation Specialist to join our team on the first shift....


  • Spring Lake, Michigan, United States Trinity Health Full time

    We are seeking a skilled Nurse to join our team at Heartwood Lodge, a member of Trinity Health Senior Communities. As a Nurse Care Specialist, you will be responsible for providing direct nursing care to our residents and supervising the day-to-day nursing activities performed by nursing shift staff.About the RoleIn this role, you will work closely with our...


  • Lake Orion, Michigan, United States American Battery Solutions Full time

    Job OverviewWe are seeking a highly skilled Advanced Battery Systems Engineer to join our team at American Battery Solutions. As a key member of our engineering group, you will be responsible for the design and development of thermal management systems for high-voltage battery packs.The ideal candidate will have a strong background in electrical engineering,...


  • Lake Odessa, Michigan, United States Workbox Staffing Full time

    We are seeking a highly skilled Diesel Mechanic/Maintenance Specialist to join our team at Workbox Staffing in Lake Odessa, MI. This is an excellent opportunity for a mechanical expert to work with diesel equipment and ensure its optimal operation.Job SummaryThe Service Technician will be responsible for performing inspections, conducting preventive...


  • Lake Angelus, Michigan, United States Jobot Full time

    We are an award-winning manufacturer of automotive systems, and we're seeking a highly skilled and experienced Permanent Regional Industrial Safety Specialist to join our dynamic team.Job DescriptionThis key role will focus on the implementation and improvement of safety measures within our manufacturing operations. The successful candidate will have a...


  • Lake Angelus, Michigan, United States Jobot Full time

    We are an award-winning manufacturer of automotive systems, seeking a highly skilled and experienced Permanent Regional Industrial Safety Specialist to join our dynamic team in the Manufacturing industry.Job DetailsThis key role will focus on the implementation and improvement of safety measures within our manufacturing operations. The successful candidate...


  • Lake Isabella, Michigan, United States InfiCare Health Full time

    As a respected healthcare provider, InfiCare Health is committed to delivering exceptional patient care and has an exciting opportunity for a skilled pharmacist to join our team as a Community Pharmacy Contract Specialist in Lake Isabella, California.About the OpportunityWe are seeking a highly qualified pharmacist with excellent communication skills to fill...


  • Walled Lake, Michigan, United States Dansources Technical Services Full time

    About the RoleWe are seeking an experienced Industrial Electronics Specialist to join our team at Dansources Technical Services.Location: Sterling Heights, MIJob Description:The successful candidate will have prior work history and a proven track record in configuring, operating, and maintaining hand-held portable computers, desktop systems, and servers, as...


  • Spring Lake, Michigan, United States CAREWATCH OF MICHIGAN HOME CARE Full time

    Job OverviewWe are seeking an experienced Caregiver to provide high-quality support services to our clients in Spring Lake, MI.CompensationThe estimated salary for this position is $18-$22 per hour, depending on experience.ResponsibilitiesAssist clients with daily activities such as dressing, bathing, and groomingProvide emotional support and...


  • Spring Lake, Michigan, United States HermanMiller Full time

    Co-Op Operations Engineering Role at MillerKnollWe're seeking a talented and motivated Operations Engineering Co-Op to join our team at MillerKnoll. As a Co-Op, you'll work on state-of-the-art custom engineered manufacturing equipment, focusing on process flow and equipment development.Responsibilities:Gain experience in process changes, problem-solving,...


  • Spring Lake, Michigan, United States CURE International Children's Hospitals Full time

    Job Overview:CURE International Children's Hospitals seeks a highly skilled Supply Chain Logistics Coordinator to join its team. This role plays a critical part in ensuring the smooth operation of our hospital supply chain.Salary Estimate:$65,000 - $80,000 per yearKey Responsibilities:- Coordinate and execute purchasing processes, including sourcing...


  • Spring Lake, Michigan, United States Garrison Dental Solutions LLC Full time

    Garrison Dental Solutions LLC is a private, purpose-driven business that values innovation and dedication to improving dentistry worldwide. As a leading provider of dental solutions, we are seeking a highly motivated Sales Development Representative to join our team.As an integral part of our sales department, you will be responsible for driving revenue...


  • Lake Orion, Michigan, United States American Battery Solutions Full time

    OverviewAmerican Battery Solutions Inc. is a leading manufacturer of advanced batteries for commercial, fleet, and industrial on- and off-road vehicles.SalaryWe offer a competitive salary range of $90,000 - $110,000 per year, depending on experience, plus comprehensive benefits.Job DescriptionThe Field Service Specialist will be responsible for building...


  • Lake Orion, Michigan, United States Midwest Vision Partners Full time

    Job OverviewThe Midwest Vision Partners are seeking a highly skilled Medical Support Specialist to join our team in providing exceptional care to patients in a clinic setting. This is a fantastic opportunity to work with a dynamic and dedicated team, utilizing your expertise in medical support to make a real difference in people's lives.About the Role:We are...