Engineer II, Validation

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company's Total Rewards (~~~)

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement - eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Summary:

Validation Engineer for Metrology will support the Analytical R&D group scheduling of priorities for analytical equipment and instrumentation. The incumbent will write, complete, and approve qualification procedures for analytical laboratory equipment and instruments, i.e., IQ/OQ/PQ processes as described by cGMP, 21 CFR Part 11, ICH, and Gamp 5.

Functions:

Provide project-metrology services for a variety of metrology-related projects. This position can lead a small group of technically diverse individuals to develop project scope, initiate a capital funds request, specify equipment and installation requirements, coordinate vendors, and finalize documentation following acceptable metrology practices for projects.

Serve as a technical resource to other personnel on site and perform each duty associated with the AR&D and QC group as needed.

Administer, document, and maintain the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of the Quality Systems tools, as well as direct actions.

Job Scope:

• Installation and Qualification of Laboratory Equipment

• Develop source documents consisting of:?

• Project Plan (QPP)?

• User Requirements Specification (URS)?

• System Impact Assessment (SIA)?

• Criticality Assessment (CA)?

• Project Risk Assessment (RA)?

• Qualification Project Plan Summary Report?

• Develop and implement qualification protocols (IOQ)?

• Develop qualification summary reports (QSR)?

Education:

Bachelor's of Science in Engineering, Biology, Chemistry, equivalent degree with commensurate work experience.

Experience:

Minimum 2 years of experience in a related field.

Equivalency:

Equivalent combinations of education, training, and meaningful work experience may be considered.

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.