We are looking for a Validation Specialist IV - 8268039, working in the Biotechnology/Medical Devices industry in Pennsylvania, United States.
• Support the development of validation strategy, including preparation of key documentation such as risk assessments, protocols and validation project plans
• Gather and analyze information and data from regulations, industry practices, vendors, guidelines, procedures, historical reports, and existing manufacturing facilities on site, in order to design and support transfer and implementation of process in new facility
• Design and execute engineering runs / process studies / equipment performance qualification / integrated functional testing, collate results and perform data analysis, interpret data, & draw conclusions. Document and interpret study results providing recommendations back to project team and Sanofi Pasteur management.
• Troubleshoot and identify corrective actions for issues and deviations on process and equipment systems
• Interface with suppliers and vendors to gather and interpret technical information provided to Sanofi Pasteur in order to assess for impact to manufacturing process, as well as recommend validation strategies as a result of that information
• Participate on cross-functional project teams in the planning and execution of project deliverables including engineering, investigational, or validation runs as required
• Manage project timelines to ensure deliverables are met on time and on budget
Project work must be conducted independently with direction and oversight from the area technical lead, and requires successful application of scientific and engineering problem solving skills. The candidate will also be required to obtain a basic working knowledge of company-specific systems, standards, and procedures. Periodic checks and reports are required to review soundness of technical judgment and the status / schedule of the effort.
Degree in chemical or biological engineering (or similar), with > 3 years of experience in Vaccine, Biologic, or Pharmaceutical manufacturing with focus on process and equipment
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Required Qualifications: Experience with performance qualification (PQ) and / or process validation (PV / PPQ) Demonstrated interpersonal skill, including flexibility and ability to work in a team environment Proven analytical abilities, including ability to perform basic statistics Demonstrated written and verbal communication skills Ability to work both independently and as part of a project team collaborating with members from Manufacturing/Operations, Manufacturing Technology, Validation, Automation and Quality Demonstrated technical problem-solving, communication, and collaboration skills Demonstrated organization skills, ability to multitask, and work in a dynamic environment Preferred Experience: Experience with facility start-up and engineering runs Experience with MS Visio, MS Project, Visual Basic, and DeltaV Good understanding of basic lab skills including aseptic technique, proper usage of measuring apparatuses, biosafety cabinet usage, etc.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.