Business Technology Validation Specialist

CSL Behring King Of Prussia , PA 19406

Posted 2 months ago

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!


The BT Validation Specialist will be responsible for ensuring computer systems are validated according to their risk profile and the requirements of the CSL Computer System Validation Master Plan. Assists in risk assessments and the update of software development/implementation lifecycle documents. Oversees testing as require and provides advice and participation in project team activities with respect to the validation of new and existing computerized business applications and other software systems.


  • Ensures computer systems are validated according to CSL's Computerized Quality Management System

  • Participates on project teams and supports the validation of business applications and other software systems

  • Trains staff on validation and risk assessments; leads and mentors junior BT Validation staff, as required

  • Leads risk assessments and prepares plans, protocols and reports in line with regulatory requirements and practices

  • Organizes and oversees testing as required

  • Prepare plans, protocols and reports in line with cGxP/ regulatory requirements and practices.

  • Review and approve (as Subject Matter Expert) vendor supplied protocols and reports.

  • Assist in the update of software development / implementation lifecycle documents



  • Bachelor's degree or equivalent; education preferably concentrated in IT, Engineering or Science
  • 3-5 years' experience in IT Quality and Validation


  • Communicates Effectively

  • Customer Focus

  • Strong organizational, collaborative, and interpersonal skills


  • Ability to effectively train others

  • Knowledge of cGxP, GAMP5, and validation practices

#behring #LI-TD1


Worker Type:


Worker Sub Type:


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Technology Manager


Posted 7 days ago

VIEW JOBS 5/24/2020 12:00:00 AM 2020-08-22T00:00 Site Name: USA - Pennsylvania - King of Prussia Posted Date: Feb 10 2020 Are you energized by a highly technical manufacturing role that allows you to accelerate efficiency and shape product quality? If so, this Technology Manager role could be an ideal opportunity to explore. As a Technology Manager, you will manage certain elements (such as upstream or downstream etc.) of the transfer of primary biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organizations to GMS Biopharm and from GMS Biopharm to other biopharmaceutical manufacturing sites. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Support the introduction and possible scale-up of primary(drug substance) processes transferred from R&D or third party clients for specific products new within GMS Biopharm. * Act as technical GMS Biopharm representative on the technology transfer teams and product development project team for specific products. * Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise. * Responsible for process trend analysis and assurance that processes remain within control parameters. * Provide technical training to production staff for new equipment and process technologies as required. * Evaluate new technologies for GSK and define technology introduction strategies. * Ensure technical accuracy of process documentation and related documentation for specific products. * May need to contribute to technical oversight of manufacturing operations, facility changes or coordinating technical activities for specific products at GMS Biopharm. * Contribute to evaluations of potential fit of prospective new products into GMS Biopharm Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelor's degree in biology, chemistry, engineering or equivalent * 5 or more years of work in Good Manufacturing Practices (GMP) regulated pharma/biotech environment * Experience developing process control strategies and Continuous Process Verification * Experience with root cause analysis and evaluating variables influencing process performance Preferred Qualifications: If you have the following characteristics, it would be a plus: * Master's degree in biology, biochemistry or chemistry * Ability to problem solve and identify technical/scientific solutions to resolve process-related issues * Strong interpersonal and relationship building skills * Ability to influence and gain support on complex issues Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk * Managing individual and team performance. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Implementing change initiatives and leading change. * Sustaining energy and well-being, building resilience in teams. * Continuously looking for opportunities to learn, build skills and share learning both internally and externally. * Developing people and building a talent pipeline. * Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. * Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. * Budgeting and forecasting, commercial and financial acumen. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site. Glaxosmithkline King Of Prussia PA

Business Technology Validation Specialist

CSL Behring