Validation specialist equipment & software i Solna

Publicerad: 2017-05-19
Solna, Stockholms län
Life Science
Läkemedel, bioteknik & medicinteknik
Ellinor Crafoord
Are you experienced in equipment and software validation? Do you have a good knowledge on IQ/OQ/PQ? Have you already worked in in vitro diagnostics/ medical devices area? Then you can be the right candidate for an exciting opportunity in Cepheids quality team.

As Validation Specialist you will be in collaboration with Technical Operations and Manufacturing management to schedule, plan, coordinate and document the validation of simple to complex systems used for the production of In Vitro Diagnostics reagents and kits. Your rigor and your writing skills will ensure the compliance of production systems with applicable regulatory requirements. Cepheid offers an dynamic and collaborative role with many interphases in a fast growing company with many frontline products.

Tasks included in the work are:

• Maintain the Validation Master Plan and define the annual Validation Plan

• Ensure that a risk based approach for validation strategy and prioritization is available

• Ensure completion of new system validations and re-validations with respect to the schedule

• Develop validation protocols, and ensure traceability of validation criteria

• Approve test method validation documentation

• Promote and develop standard work and documentation to facilitate validation files review during internal or external audits and inspections.

• University degree in engineering, science or equivalent.

• At least three years experience in validation of systems, preferably in the medical diagnostics / pharmaceutical industry

• Knowledge of risk management tools (FMEA, FTA etc..)

• Excellent skills in Swedish and English both in written and verbally

As a person you are careful and have good organizational skills. You have excellent interpersonal skills and have the ability to communicate with colleagues throughout the organization. You are self-motivated and have good decision making abilities as well as high problem solving and prioritizing abilities. The role requires that you have leadership skills and can power your and others' work ahead in an independent way.

Business: Cepheid

City: Solna

Employment: Open ended full time

Last date of application: 2017-06-02

For information: In this recruitment Cepheid is collaborating with Dfind Science & Engineering. For questions please contact responsible recruitment consultant Ellinor Crafoord 0733-434502. Apply via not later than 2017-06-02

Organization and Business description:

Cepheid is one of the fastest growing companies in molecular diagnostics. The company's unique diagnostic platform is used throughout the world, making a difference for patients as diagnosis and choice of treatment is facilitated by the test results. Cepheid offers a broad range of diagnostic products in virology, bacteriology and oncology that can meet tomorrow's demands for safe, fast and flexible diagnostic both in Western countries and in countries with limited resources. Globally, the company is represented by its headquarters in Sunnyvale, California, sales and marketing offices in Toulouse, France and technology and chemistry center in Bothell, Washington. Cepheid AB, part of the global Cepheid group, is located in Solna, Sweden and has around two hundred employees, mainly in production, quality control, research and development.