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Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)- Quality Assurance, Validation. Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable.
Essential Duties and Responsibilities
Demonstrated competency in one or more of sterilization technologies including Radiation Sterilization and ethylene oxide/ Sterilization with gases and aseptic processing. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Effectively operate in and may facilitate cross-functional teams with guidance. Must be able to provide solutions that reflect understanding business objectives and cost implications.
- Contribute to technical feasibility analysis of complex research and design concepts for the sterility assurance and related controls for the products.
- Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle-time.
- Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical device, Solutions & pharmaceutical projects.
Perform standard sterilization engineering assignments for application, validity, and conformance to specifications.
Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives.
Study and recommend techniques to improve existing products/processes and process controls.
- Provide sterilization support for R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals
- Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP).
- Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction.
- Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.
- Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
- Develop reports and presentations on technical plans and results.
Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Knowledge around microbiological aspects of Biological indicators, Adventitious Agents, and related microbiological concepts.
Qualifications
- Master’s degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 8 years or BS with minimum 10 years’ experience in sterilization validation or equivalent.
Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods (e.g., "six sigma")
Display a solid technical understanding of Sterilization Engineering principles and qualification practices & application of these principles on individual/small projects.
- The position requires technical skills for device sterilization using Gas (EO/VHP) / Radiation, assessing critical changes & impact assessments, and writing study rationale documents.
- Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies.
Skills
Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones.- Proficient with Sterilization validation principles and related testing for Biological indicators etc.
- Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators.
- Highly adept at grasping and solving complex problems using root-cause analysis techniques.
- Ability to objectively identify technical solutions and make sound decisions
- Project management experience for Quality & value improvement projects
- Self-driven, resourceful, and able to work on multiple projects and priorities.
- Strong organization, attention to detail, and documentation skills.
- Strong acquaintance with technology, QMS tools and collaboration tools over the web: e.g. Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc.
A Career That Matters
Vantive’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific
innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and
technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing
creative collaborations that bring our mission to life for patients every day.
Equal Employment Opportunity
Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion,
gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other
legally protected characteristics.
