Validation Engineer II

4 days left

Thermo Fisher Scientific
Carlsbad, CA
Jul 29, 2021
Aug 03, 2021
Organization Type
Job Title: Validation Engineer II

Requisition ID: 164725BR

When youre a part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

How will you make an impact?

The Equipment Validation Engineer will be responsible for a variety of equipment validation projects. This position requires a problem-solving mindset with strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Equipment Services and other groups.

What will you do?

* Apply risk-based principles and strategies in the qualification of manufacturing equipment used in the production of commercial manufacturing, packaging, and warehousing of products.
* Maintain the qualified state of manufacturing equipment throughout the equipment lifecycle in compliance IAW ISO 9001:2015 Quality policies/procedures including support of periodic review, event/time-based requalification, and decommissioning.
* Serve as a Validation technical subject matter expert (SME) in support of department, cross-functional, and network initiatives.
* Provide input to the development of personal performance goals and departmental objectives.
* Collaborate with Management to establish and meet targets and timelines.
* Manage competing priorities.
* Identify, design, and implement process and system improvements.
* Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
* Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships.
* Train personnel and internal customers on relevant business processes.

* Author, review and approve Change Control documentations for validation, equipment, facility/utility and/or automation changes. Manage on-time implementation and close-out to meet project, production and supply timelines.
* Carry out responsibilities in accordance with the company policies and procedures.
* Manage the validation deliverables of assigned projects (equipment including custom automation, SUTs, process, etc.) ensuring new equipment and systems are implemented within predetermined timelines and financial forecasts, escalating any potential misses and develop remediation plans when possible.
* Participate in cross functional teams/initiatives and act as individual contributor to drive validation activities, change control and improvement projects, including projects aimed at improving Right-First-Time performance, and value capture projects to improve yield, reduce cost, or lower our processing cycle times.
* Review/approve validation deliverable documents like protocols, plans, etc., execute studies and report results/conclusions utilizing sound science-based rationales and engineering principles to support SSFP qualification projects as required per QMS.
* Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
* Provide input into the design and presentation of department performance metrics.

How will you get there?

* Bachelor's degree in Engineering, Life Sciences, or related discipline preferred but not required.
* Minimum of 3+ years of relevant experience in equipment validation required.
* Technical expertise to define validation approaches and execute validation activities in accordance with QMS and applicable regulations, procedures and industry guidance.
* A desire to learn and a passion to contribute
* A collaborative spirit and strong project management capabilities.
* Knowledge and experience with GMP and ASTM E2500 validation approach is preferred.
* Ability to independently evaluate technical challenges and propose potential solutions.
* Ability to communicate clearly and professionally in writing and verbally.
* Basic understanding of data and statistical analysis
* Flexibility with work hours to meet business needs.
* Must embrace and encourage diversity and inclusion and possess the willingness to challenge the status quo.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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