Validation Technician II at Thermo Fisher Scientific in Tewksbury, Massachusetts

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards



Job Description



When you're part of the team at Thermo Fisher Scientific, you'll do important work surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected organization has an outstanding strategy for the near term and beyond! Take your place on our strong team and help us make substantial contributions to the world.



Job Summary:

The Validation Technician II will assist with the day-to-day operations of the production team, perform routine calibrations of sophisticated laboratory and/or production equipment following Standard Operating Procedures (SOP's).


This position is a mid-level technician role. The candidate will work in a production validation environment to setup, validate, and modify portable X-ray based instruments. The instruments are used in a wide variety of industries to detect and report the composition of periodic table-based elements in various materials. The instruments are a mix of new production units and customer owned units that require validation. The candidate will be trained to work with high technology instruments, data acquisition systems, combined with standard industry software. This role is not a tool or measuring tool calibration position.


Required Skills:

• Familiarity with portable instrumentation setup and validation.


• Experience running automated or robotic manufacturing equipment.


• Ability to use software systems; small screen, iPhone/Android style operating systems.


• Ability to learn and master new technical ideas and concepts.


• Cross-training capability, and team-based thinking are highly valued.


• Capability to use math and simple calculations to review measured values against certified values.


• This includes proper documentation of work performed, evaluation of out of tolerance results, oversight of vendor performed calibrations, and coordination of services.

Minimum Responsibilities:

• Work under general guidance to validate and test X-ray instruments manually and on robotic systems.


• Connect instruments to network based data systems to modify instrument parameters.


• Troubleshoot/resolve failing instruments to point of passing specifications.


• Generate specifications and documentation used to pass instrument checkpoints.


• Processing validation for multiple instruments at one time.


• Indicate work instruction changes and suggest changes to written work instructions.


• Accurate preparation and handling of test samples.


• Adhere to PPE (Personal Protective Equipment) policies.


• Participate in daily team stand-up meetings, communicating daily challenges and/or ideas.


• Participate in improvement events (such as Kaizen, 6S, Practical Process Improvement).


• Maintain a safe working environment and follow established 6S procedures.


• Train technicians.


• Assist in the development/execution of equipment calibration activities.


• Develop equipment calibration procedures, work instructions and templates.

Qualifications:


Required:

• A high school diploma or equivalent.


• Previous validation and calibration experience is a plus.


• Intermediate ability to troubleshoot repair, align and optimize precision equipment.


• Intermediate in Microsoft Word, Excel, and Power Point.


• Ability to work independently and/or in a team environment.

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