Field Validation Engineer Ii

Job Description

Unity Lab Services, a part of Thermo Fisher Scientific, provides a broad portfolio of services to research, production, and clinical customers across all industries. These services include instrument and equipment service, asset management programs, chemical and consumable supply management solutions, and laboratory support services.

This is a remote position where ideally the Engineer will live within 50 miles of San Diego and travel daily to customer sites to ensure customer happiness by providing installation qualification, operational qualification and performance qualification (temperature mapping), that keeps equipment operating safely and efficiently. Provides support to one or more Thermo product lines or applications. Actively promotes service offerings, new products, and upgrades. As such, the Validation Engineer will be provided a Fleet vehicle.

Key Responsibilities:

• Familiar with industry standards and regulatory guidelines.
• Delivers work within established timelines.
• Evaluate and calibrate the equipment, review procedures used in development and production of a variety of products.
• Establish validation standards, prepare testing protocols, prepare equipment, document test results, and maintain records for later analysis.
• Coordinate with other personnel or departments who will be impacted by testing.
• Ensure all systems are running according to specifications and operate within regulations to ensure the production of quality products.
• Performs technical evaluations on product changes and on new products, including software verification, collection of performance data, assessment of user-friendliness, ease of maintenance, etc. Provide written reports on evaluations.
• Conduct validation or qualification tests of new or existing equipment, or software in accordance with internal protocols or external standards
• Prepare detailed reports based on the results of validation and qualification tests.
• Enters data (i.e. service log, invoicing, knowledge retention, etc.) into both customers and Thermo Fisher computer systems
• Ensures customer happiness through excellence in the repair and support of customers’ products.
• Maintains communication with customers to ensure understanding of the status, cost, and timing of all aspects of the service event.
• Provides professional and knowledgeable responses to technical issues, meeting customer requirements.
• Act as a customer advocate and ensure that technical issues are resolved in a timely manner.
• Supports the Clients and Thermo Fisher Quality Systems and Quality Policies by following procedures/work instructions to generate records meeting the Quality System Regulation requirements and ISO registration requirements.
• Maintains records of all service events per company policy.
• Promotes and sells various types of extended warranty/PM contracts on equipment, user training, and Service Replacement Orders.
• Communicate with sales representatives about potential selling opportunities within accounts

Minimum Requirements/Qualifications:

• High school diploma or GED equivalent!
• 3 years of related Quality Assurance or Validation experience including GxP and Good Documentation Practices.
• Proficient user of Microsoft Word, Excel, Outlook, and Technical Writing.
• Ability to work overtime and/or outside regular business hours, and/or on-call work.
• Ability to travel overnight (approximately 30%) and sometimes on short notice.
• Maintain a valid driver’s license and safe driving record.
• Qualifying Thermo Fisher CTU’s
• Qualifying Non-Thermo Fisher Instruments (Autoclaves, HPLC, King Fisher, Mass Spec, etc…)

Typical Knowledge, Skills, and Abilities

• Strong problem-solving skills.
• Proficient verbal and written communication skills. Bilingual a plus but not required.
• Ability to balance multiple priorities.
• Strong interpersonal, self-motivational, & negotiating skills.
• Strong technical proficiency in instrumentation and electronics.

Physical/Environmental requirements:

While performing the job duties, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and taste or smell. The Engineer is occasionally required to climb or balance and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception. Regularly lift or carry up to 30 pounds; and occasionally 75+ pounds.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards