Validation Manager, CSV

1 month ago

College Station, Texas, United States FUJIFILM Corporation Full time
About This Role

FUJIFILM Diosynth Biotechnologies is a leading manufacturer of biotherapeutics and vaccines. We are seeking a highly skilled and experienced Validation Manager, CSV to join our team.

Key Responsibilities
  • Manage, schedule, and oversee all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle.
  • Ensure compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
  • Lead the development and approval of validation documentation, risk assessments, and impact assessments of proposed changes to computerized systems.
  • Supervise the activities of internal validation staff and external validation contractors.
  • Establish validation priorities to ensure deadlines are met.

Requirements

  • Master's Degree and 5+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Or Bachelor's Degree and 7+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Degree in Engineering or Science discipline is preferred.
  • 4+ years' experience in supervision of personnel.
  • Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.

Working with Us

FUJIFILM Diosynth Biotechnologies is a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.

  • Life Sciences Manufacturing Expert

    3 days ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec is a global provider of system validation and lifecycle services, offering commissioning and qualification of computerized systems for clients in the Life Sciences industry.We are seeking a skilled Computerized Systems Validator to join our team in Texas. The ideal candidate will have a strong background in CSV and validation, with...

  • Process Improvement Manager

    3 days ago

    College Station, Texas, United States PSC Biotech Full time

    About PSC BiotechPSC Biotech provides essential services to ensure health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.About the RoleThis is a W2 Temp position that requires an experienced Process Improvement Manager to oversee our production and validation...

  • Caregiver Services Manager

    2 weeks ago

    College Station, Texas, United States AccentCare Full time

    Overview:We are seeking an experienced Caregiver Services Manager to join our team at AccentCare in College Station, Texas. This role requires a strong passion for patient care and excellent organizational skills.In this position, you will be responsible for supervising a team of caregivers, ensuring that services are provided in accordance with...

  • Calibration Operations Manager

    3 weeks ago

    College Station, Texas, United States BioPharma Consulting JAD Group Full time

    About Us: BioPharma Consulting JAD Group is a leading provider of calibration services to the biotechnology industry.">Job Summary: We are seeking an experienced Calibration Operations Manager to join our team. The successful candidate will be responsible for ensuring the effective planning, scheduling, and execution of calibration activities across multiple...

  • Quality Assurance Specialist

    3 days ago

    College Station, Texas, United States PSC Biotech Full time

    Job SummaryWe are seeking an experienced Quality Assurance Specialist to join our team at PSC Biotech. This role involves ensuring the highest quality standards in our production and validation processes, implementing process improvements, and conducting thorough investigations, risk management, and corrective action implementation to ensure regulatory...

  • Senior Quality Assurance Specialist

    3 weeks ago

    College Station, Texas, United States PSC Biotech Full time

    Job OverviewPSC Biotech is a leading provider of essential services to the life sciences industry, ensuring that healthcare products meet the highest standards and regulatory requirements. We are seeking an experienced Quality Engineer to join our team.About the RoleThe successful candidate will be responsible for ensuring quality standards in production and...

  • Quality Assurance Specialist

    3 weeks ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec is a leading provider of system validation and lifecycle services, offering commissioning and qualification of computerized systems for clients in the Life Sciences industry. With a strong mission to provide comprehensive services that help clients meet their capital project and lifecycle maintenance goals, Valspec ensures seamless...

  • Rehabilitation Specialist

    4 days ago

    College Station, Texas, United States EnhabitADVANCED HOMECARE MANAGEMENT INC Full time

    About the Role:We are looking for an experienced Physical Therapist to join our team at Enhabit/ADVANCED HOMECARE MANAGEMENT INC. The successful candidate will work closely with patients, families, and healthcare professionals to develop and implement individualized plans of care.Key Responsibilities:Conduct comprehensive assessments of patients' physical...

  • Transportation Specialist

    4 weeks ago

    College Station, Texas, United States College Station ISD Full time

    Job Title: Transportation SpecialistAbout the Role:We are seeking a skilled and safety-conscious Transportation Specialist to join our team at College Station ISD. As a key member of our transportation department, you will be responsible for ensuring the safe and efficient transportation of students and staff.About the Job:The Transportation Specialist will...

  • Food Delivery Driver

    2 weeks ago

    College Station, Texas, United States DoorDash Full time

    About DoorDashDoorDash is a leading on-demand logistics company that connects consumers with local businesses and drivers. Our platform provides an opportunity for individuals to earn money by delivering food and other items in their area.Job SummaryWe are seeking reliable and motivated individuals to join our team of Dashers. As a Dasher, you will have the...

  • Regional Truck Driver

    6 days ago

    College Station, Texas, United States LuXX Management Full time

    Job DetailsWe are currently seeking experienced Long Haul CDL-A Regional Truck Drivers to join our team at LuXX Management. As a key member of our transportation team, you will be responsible for hauling goods across the country in a safe and timely manner.Salary and Compensation:Estimated weekly earnings: $1,200 - $1,400 (based on industry standards)Job...

  • Key Account Strategist

    3 weeks ago

    College Station, Texas, United States Kevin's Landscapes Full time

    Job OverviewWe are looking for a highly organized sales and marketing professional to assist in the advertising and selling of our company's product, creating competitive advantages in the market industry.Duties and ResponsibilitiesRecruiting, training, scheduling, coaching, and managing sales and marketing teams to meet sales and marketing...

  • Direct Support Professional

    4 days ago

    College Station, Texas, United States Sevita Full time

    About SevitaWe are a leading provider of home and community-based specialized healthcare services, committed to empowering individuals with intellectual and developmental disabilities to live full, more independent lives. Our mission-driven team strives to provide quality services and individualized supports that lead to growth and independence.">Why Work...

  • Roofing Sales Professional

    3 days ago

    College Station, Texas, United States ASAP Roofing Full time

    Job Summary: We are seeking a motivated and results-driven individual to join our team as a Roofing Sales Representative. This role involves generating leads, presenting solutions to homeowners, and closing sales to drive revenue growth. The ideal candidate will have a strong work ethic, a willingness to learn, and a goal-driven mindset. They should also...

  • Regional Trucking Position with Competitive Pay

    2 weeks ago

    College Station, Texas, United States LuXX Management Full time

    LuXX Management is seeking an experienced CDL-A Regional Truck Driver to cover 10-14 day regional routes.About the JobThis role offers a unique opportunity for truckers to enjoy regular home time, averaging 1 day off every 6 days on the road. The regional schedule allows drivers to spend 10-14 days out and return home regularly.Miles: Average 2,200-2,400...

  • Computer Hardware Specialist

    6 days ago

    College Station, Texas, United States SMARTECH and Associates, LP Full time

    We are seeking a skilled Computer Hardware Specialist to join our team in the Bryan/College Station area. This is an excellent opportunity for individuals who enjoy working with computer hardware and providing top-notch service to clients.About the JobAs a Computer Hardware Specialist, you will be responsible for repairing and maintaining computer hardware...

  • Registered Nurse

    4 days ago

    College Station, Texas, United States BrightSpring Health Services Full time

    About the PositionWe are seeking a skilled Registered Nurse - Home Health to join our team at BrightSpring Health Services. As a key member of our infusion services, you will provide high-quality patient care and support in the comfort of patients' homes.About the RoleThis is a PRN opportunity for a Registered Nurse with experience in infusion therapy. The...

  • Specialty Care Professional

    5 days ago

    College Station, Texas, United States BrightSpring Health Services Full time

    Job SummaryWe are seeking a skilled Specialty Care Professional to join our team at BrightSpring Health Services. As a key member of our infusion services, you will provide high-quality patient care and support in the comfort of patients' homes.About the RoleThis is a PRN opportunity for a Registered Nurse with experience in infusion therapy. The ideal...

  • Clinical Team Leader

    3 weeks ago

    College Station, Texas, United States Enhabit Inc Full time

    Clinical Team Leader Role Overview:As a seasoned Nurse Clinician, you will play a pivotal role in ensuring the delivery of exceptional hospice care services to patients. Reporting directly to the Branch Director, this position demands strong leadership and organizational skills to coordinate patient care teams effectively.The ideal candidate will possess a...

  • Ecommerce Seasonal Fulfillment Associate

    2 weeks ago

    College Station, Texas, United States KALCORP ENTERPRISES Full time

    Job OverviewKALCORP ENTERPRISES is seeking a highly motivated and detail-oriented Ecommerce Seasonal Fulfillment Associate to join our team. The successful candidate will play a vital role in ensuring timely and accurate fulfillment of online orders placed on our ecommerce site.In this exciting opportunity, you will have the chance to add value to our...