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Validation Engineer

2 months ago

Oro Valley, United States Solü Technology Partners Full time

Our partner ranks among the world’s prominent corporations in the biotechnology industry. Working on their team means you’ll impact the lives of millions of patients and be a part of a culture of innovation, curiosity, and diversity.


PLEASE NOTE THIS POSITION IS 100% ONSITE SO LOCAL CANDIDATES ONLY - OUT OF STATE CANDIDATES MAY APPLY, BUT ARE RESPONSIBLE FOR MOVING THEMSELVES TO THE TUCSON, AZ AREA


NO C2C PLEASE


Job Description

The position will be supporting the Senior staff. Must be detail oriented and experienced in process validation and testing of products. Must have experience working in a lab. Medical Device background desired but will consider other experience. Mechanical Engineering experience is ok.


The Validation Engineer will be responsible to ensure that validation requirements are met for all existing and new equipment/ facilities/utilities and processes by preparing and executing detailed validation protocols that meet the relevant testing standards and any requirements.



Responsibilities

• Designs and drafts validation sampling and testing plan/protocols.

• Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.

• Resolve technical issues encountered during study execution.

• Track and expedite the review and sign-off of qualification documentation.

• Support execution of validation activities.

• Interact with individuals from different departments to plan, execute, and complete qualification activities.

• Drive the completion of validation efforts according to deadlines.

• Write / guide the writing of departmental procedures required for validation.

• Assist during internal and 3rd party audits wrt validation requirements.

• Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.

• Assist with identifying maintenance and calibration requirements.

• Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.

• Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.

• Review Validation plans, protocols and SOPs written by other validation team members.

• Manage workload arising from unscheduled events.

• Other duties as assigned by management.



Qualifications

• 1 - 2 years of experience, someone they can train. Internships would be considered as experience.

• Working knowledge of ISO Quality Management systems would be preferred

• Scientific or Engineering Degree required


Additional Information

LOCAL CANDIDATES ONLY - 100% ONSITE - OUT OF STATE CANDIDATES MAY APPLY BUT MUST RELOCATE THEMSELVES TO THE TUCSON, AZ AREA AND BE ABLE TO START ONSITE 2 WEEKS FROM OFFER.



*Solü Technology Partners provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability or genetics.