You manage validation processes and equipment qualifications, ensuring compliance with current standards while driving improvements and collaborating with external partners.
Anforderungen
- •Bachelor's degree in scientific discipline
- •2 years of industry experience in sterilization
- •Strong statistical expertise
- •Ability to understand regulatory standards
- •Experience with ISO 13485
- •Fluent in English
- •Good technical writing skills
- •Experience of manufacturing process needs
- •Systematic approach to improve processes
Deine Aufgaben
- •Develop process validation and equipment qualification.
- •Lead equipment qualification activities such as FAT, SAT, and IQ.
- •Execute sterilization requalification runs per global protocols.
- •Conduct upstream and downstream process qualifications.
- •Maintain and update sterilization documentation to current standards.
- •Assist in creating and evaluating technical sterilization specifications.
- •Establish maintenance and calibration procedures.
- •Drive process and equipment improvements.
- •Coordinate with external suppliers and laboratories.
Deine Vorteile
Competitive salary
Flexible benefits package
Wide range of benefits
Career support resources
Life stage support
Competitive compensation plans
Original Beschreibung
# Validation Engineer
**Lausanne, Vaud, Switzerland** | **Full time**
# A Day in the Life
Responsibilities may include the following and other duties may be assigned.
**Main** **task:**
* Develop process validation & equipment qualification in collaboration of global entities (sterilization or other processes)
* Lead equipment qualification (e.g FAT, SAT, IQ )
* Execute sterilization (re)qualification runs as per protocol defined by global entities.
* Execute down stream process and upstream process qualifications
* Ensure company documentation related to sterilization are maintained and updated with most current regulations, standards, and industry practices.
* Contribute to the creation and evaluation of technical sterilization and microbial specifications.
* Establish procedure for maintenance and calibration procedure
* Drive improvements to process and equipment under development
* Coordination with external supplier or laboratories used during the activities
**Critical Knowledge and Qualifications:**
* Minimum Bachelor’s degree in a relevant scientific discipline (preferably biology).
* Industry Experience: Preferably 2 years in product sterilization or autoclaving or sanitization within medical device or pharmaceutical sectors
* Data Analysis: Strong statistical expertise.
* Demonstrated ability to understand and apply relevant regulatory standards (or ability to rapidly develop expertise to function independently with minimal supervision)
* Quality Management: ISO 13485
**Critical Skills/technical Know-how**
* Fluency in English is mandatory, other languages are welcome.
* Good technical writing & communication skills
* Comprehensive experience of manufacturing process needs
* Systematic and standardized approach to improve processes or solve problems
**TECHNICAL SPECIALIST CAREER STREAM:** An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
# Benefits & Compensation
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.