Senior Validation Engineer - Fill/Finish
With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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!
**Ideal candidates will have experience working in Fill/Finish or Parenteral areas**
Plans, communicates, and leads scientifically sound, risk based strategies for large scale, multi-facetted validation projects in a cGMP environment. Works closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and R&D to achieve project deliverables. Able to independently design, schedule, and execute qualification/validation experiments which demonstrate compliance with regulatory requirements, product license restrictions, and industry standards. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. Represents the validation department on cross-functional and/or global project teams.
Main Responsibilities and Accountabilities
- Responsible for testing the systems (equipment, utilities, facilities, and processes) used to develop or manufacture products in a cGMP environment.
- Plans, communicates and leads scientifically sound validation strategies for small to large scale multi-facetted validation projects including timelines, cost estimates, and assigned resources (validation contractors).
- Leads assigned resources (validation contractors) to achieve project deliverables, as required.
- Effectively schedules and communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to validation study execution/testing requirements and status of assigned execution activities.
- Prepares validation project plans, protocols, and test equipment for execution. Collects and evaluate validation test data for conformance to protocol acceptance criteria and/or to investigate and determine root cause of validation study discrepancies
- Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria.
- Able to recognize and trouble shoots problems associated with validation studies, equipment, and procedures.
- Assists in the preparation of proposals and bid packages to secure validation contractor services.
- May serve as Subject Matter Expert (SME) for review of Validation and Engineering Qualification protocols and reports for adherence to cGMPs, good documentation practices, and general quality oversight.
- Assists in review of Deviations, Change Controls, Material Change Controls, Document Change Controls as an SME for Validation.
- Provides technical support/training to Validation department personnel and other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed.
- Researches governmental regulatory requirements and industry guidance on assigned projects.
- Assists the in development of validation programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements.
- Supports the facility in internal and external inspections.
- Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “nonvalue added” activities.
- Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties/responsibilities assigned by senior management
Position Qualifications and Experience Requirements
Education and Experience
- BS in Engineering, Physical or Biological Science with 5+ years validation
experience or Associates Degree with 8+ years related validation experience.
Proven demonstration to perform in the role may also be considered.
- Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing.
- Experience in project management, problem solving analytical/conceptual thinking and time management.
- Developing skills in interpersonal communication, delegation, and decision making
- Direct interaction with FDA desirable
- General understanding of equipment qualification.
- Understanding of validation process for sterilization including moist heat (tanks, autoclave, lyophilization), dry heat (deprogenation ovens), and vaporized hydrogen peroxide sterilization (isolators).
- Experience with execution of pasteurization qualification.
- Ability to work with cross-functional team to evaluate changes to sterilization/filling process to determine validation impact.
- Experience with packaging process.
- Time Management
- Interpersonal savvy
- Action oriented
- Learning on the fly
- Problem solving
- Demonstrating CSL Values