Specialist II, Validation

Found in: beBee S US - 2 weeks ago

Holly Springs, United States CSL Behring Full time

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Reporting to the Manager of Validation, you will work a onsite at our CSL Seqirus in Holly Springs, North Carolina location, Monday - Friday. Benefits include Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Responsibilities:

  • Works independently to qualify multiple types of GMP systems (e.g., utilities, facilities, lab instruments, computer systems, cell culture process equipment, filling and packaging systems), sterilization processes, and cleaning processes. Utilizes SOPs to develop validation protocols and summary reports. Executes protocols and collects samples in support of qualification/validation studies.
  • Coordinates validation activities with the appropriate system owners and other affected departments. Integrates validation maintenance activities into site schedules.
  • Programs and calibrates temperature monitoring equipment (Kaye Validator, Lives loggers) for use in qualification protocols.
  • Data analysis skills that include the use of intermediate statistical analysis tools and interpretation of results vs. acceptance criteria and regulatory guidance.
  • Develops documentation for validation procedures and technical reports related to systems, products and/or processes.
  • Prepares validation project plans, protocols and reports on completed studies that summarize test results and conformance to defined acceptance criteria.
  • Develops programs and Standard Operating Procedures (SOPs) and provides technical support/training on validation and regulatory requirements.
  • Communicates cross functionally regarding needs and status of assigned study activities and project deliverables.

    Qualifications:

    • Bachelor degree in Engineering, Mathematics or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
    • 2+ years' quality systems/validation experience in pharmaceutical manufacturing/a highly regulated industry
    • Knowledge of cGMP
    • Knowledge of FDA and EMA requirements

      Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

      #LI-Onsite

      Our Benefits

      CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.

      Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

      We want CSL Seqirus to reflect the world around us

      As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

      Do work that matters at CSL Seqirus

      Watch our ‘On the Front Line’ video to learn more about CSL Seqirus

  • Specialist II/III,

    1 week ago

    Holly Springs, United States Seqirus U.S.A. Inc. Full time

    Specialist II/III, (Validation) - Cleaning page is loaded **Specialist II/III, (Validation) - Cleaning** **Specialist II/III, (Validation) - Cleaning** locationsSeqirus USA - NC - Holly Springs time typeFull time posted onPosted Yesterday job requisition idR-147968 **Job Purpose:** Provides validation lifecycle of processes including: Process validation,...

  • Specialist II, Validation

    Found in: beBee jobs US - 1 week ago

    Holly Springs, Georgia, United States CSL Behring Full time

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as...

  • Coding Specialist I

    Found in: beBee jobs US - 1 week ago

    Mount Holly Springs, Pennsylvania, United States CaroMont Health Full time

    Job Summary: To perform diversified coding of clinic encounters to accurately reflect the services provided in the clinic setting, using ICD-10-CM and CPT coding conventions including application of Evaluation & Management guidelines, and appropriate modifier usage. Performs abstract coding functions for each encounter coded by reviewing to validate the...

  • QA Specialist

    2 weeks ago

    Holly Springs, United States PharmEng Technology Americas Full time

    Job DescriptionJob DescriptionQA Specialist PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on...

  • Revenue Cycle Specialist II

    Found in: Whatjobs US C2 - 4 days ago

    Santa Fe Springs, United States CEDARS-SINAI Full time

    Job Description What will you be doing in this role? Under general supervision and following established practices, policies, and guidelines, provides Commercial and Government billing and collections support to Insurance Follow up and Accounts Receivable, performing duties which may include reviewing and submitting multi-specialty claims to third party...

  • Construction Specialist II

    Found in: beBee jobs US - 1 week ago

    Altamonte Springs, Florida, United States NES Fircroft Full time

    MON-FRI 10 hr days in Denver City/ Seminole areaThe ideal candidate will have a strong understanding of construction principles and practices, as well as experience working in the oil and gas industry. The Construction Specialist will be responsible for a variety of tasks, including planning and coordinating construction projects, managing budgets, and...

  • Service Desk Specialist Level 2 with TS/SCI, Day Shift

    1 week ago

    Colorado Springs, United States IMG Information Management Group, Inc. Full time

    Opportunity: Position Description: Resolves technical problems and answers queries by telephone or self-service ticket in support of internal and/or outside customer computer hardware, software, network, system/application access, and telecommunications systems. Diagnoses, identifies, isolates, and analyzes problems utilizing historical database records. May...

  • Insurance Billing Specialist and Administrative Support

    2 weeks ago

    Colorado Springs, United States MasterMind Clinic, PLLC Full time

    Job DescriptionJob DescriptionPOSITION: Insurance Billing Specialist and Administrative SupportREPORTS TO (title): Practice ManagerEFFECTIVE DATE:JOB SUMMARY:• Responsible for RCM (Revenue Cycle Management) with psychiatric mental health outpatient clinicmanaging billing process in house• Responsible for maintaining insurance contracts and...

  • Billing and Coding Specialist

    Found in: Talent US C2 - 2 weeks ago

    Colorado Springs, United States Peak Gastroenterology Associates Full time

    Job Summary:The Billing and Coding Specialist is responsible for supporting the department in maximizing revenue and cash flow by validating ICD and CPT codes, performing charge entries, following up on all outstanding A/R, including resolution of denials, and generating effective written appeals to carriers to maximize reimbursement on incorrectly denied...

  • In Vitro Laboratory Technician II

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Mardela Springs, United States Culmen International Full time

    Overview Established in 2004, Culmen International is committed to enhancing international security, strengthening homeland defense, optimizing government operations and providing humanitarian assistance around the world. We provide technical and management expertise, develop innovative technology solutions, and deliver youth care services, logistics,...

  • Executive Administrative Specialist

    Found in: Talent US C2 - 2 weeks ago

    Colorado Springs, United States ASRC Federal Holding Company Full time

    Job TitleExecutive Administrative SpecialistLocation1975 RESEARCH PKWY, COLO SPRIN-CO010Job DescriptionASRC Federal Cyber is seeking an Executive Administrative Specialist for our team in Garden of the Gods, CO. Key Role:Support a Director level office. Expedite internal/external taskings, distribute, track, and coordinate action items to closure within...

  • Document Control Specialist II

    1 week ago

    Colorado Springs, United States Arcfield Full time

    Overview: Arcfield is a leading provider of full lifecycle, mission-focused systems engineering and integration capabilities to the U.S. government and its allies. The company has more than 60 years of proven experience providing advanced engineering and analysis, IT and C5ISR capabilities to support our nations most critical national security missions....

  • Engagement Specialist

    2 weeks ago

    Bonita Springs, United States Life Home Health (FL) Full time

    Job DescriptionJob DescriptionEngagement Specialist’s to start immediatelyMust have experience working with seniors either professional or personally.  Looking for care partners to engage, transport and perform activities with our seniors. Grow with Us!  LIFE HOME HEALTH is looking for individuals who share our enthusiasm for LIFE. This is not your...

  • Sr. SAP Payroll Functional Specialist

    6 days ago

    Sandy Springs, United States Softworld Inc Full time

    SAP Payroll Functional Specialist Job Description 6 Month Contract To Hire **Onstie work in Atlanta, GA is required. 2 days/ week** The Payroll Functional Specialist is responsible for the SAP Employee Central Payroll solution/ and Time and Attendance solution by Workforce. The incumbent participates during the implementation of Success Factors and...

  • Sr. SAP Payroll Functional Specialist

    3 days ago

    Sandy Springs, United States Softworld Inc Full time

    SAP Payroll Functional Specialist Job Description 6 Month Contract To Hire **Onstie work in Atlanta, GA is required. 2 days/ week** The Payroll Functional Specialist is responsible for the SAP Employee Central Payroll solution/ and Time and Attendance solution by Workforce. The incumbent participates during the implementation of Success Factors and...

  • Cyber Task Lead

    Found in: Dice One Red US C2 - 2 weeks ago

    Colorado Springs, United States Aleut Federal LLC Full time

    Cyber Task Lead/Instructional Developer II - Officer Training Course Salary Range: $105,000 -- $140,000 Annually ***Contingent Upon Contract Award*** About Aleut Federal: At Aleut Federal, we believe the company and its mission is just as important as the job you are applying for. Aleut Federal is an Alaskan Native-owned enterprise whose purpose is to...

  • DELIVERY SPECIALIST

    Found in: Careerbuilder One Red US C2 - 3 days ago

    Palm Springs, FL, USA, United States Arona Home Essentials Full time

    Arona Home Essentials has a long legacy as an industry leader, with continued growth regardless of the economy.  We are built on a foundation of excellence, customer focus, quality products and services. We operate 50 stores in Iowa, Nebraska, Illinois, Michigan, Florida, Colorado, Missouri, Kentucky, Puerto Rico and Indiana.  We are currently looking for...

  • Document Control Specialist II

    Found in: Resume Library US A2 - 2 weeks ago

    Colorado Springs, Colorado, United States Arcfield Full time

    Overview: Arcfield is a leading provider of full lifecycle, mission-focused systems engineering and integration capabilities to the U.S. government and its allies. The company has more than 60 years of proven experience providing advanced engineering and analysis, IT and C5ISR capabilities to support our nation’s most critical national security missions....

  • Space Electronic Warfare Instructor II

    Found in: Dice One Red US C2 - 1 week ago

    Colorado Springs, United States Aleut Federal LLC Full time

    Space Electronic Warfare Instructor II - Officer Training Course. Salary Range: $100,000 -- $125,000. Contingent Upon Contract Award (Anticipated May 2024) About Aleut Federal: At Aleut Federal, we believe the company and its mission is just as important as the job you are applying for. Aleut Federal is an Alaskan Native-owned enterprise whose purpose is to...

  • Specialist, Technical Writer with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Colorado Springs, United States L3Harris Technologies Full time

    Job Title: Specialist, Technical Writer Job Code: 10487 Job Location: Colorado Springs Job Description: L3Harris Technologies Inc. is seeking an experienced Technical Writer to join our team in supporting Technical Writing and Technical Training development activities for the Space Command and Control (C2) Mission Systems program, under the under the...