Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Engineer, Technical Operations

Reports to: Manager Technical Operations

How Will You Make an Impact?

At Thermo Fisher Scientific Inc., you will be part of a world-class team that is determined to make a positive impact on the world. This is an outstanding opportunity to be at the forefront of innovation and excellence, supporting groundbreaking projects and ensuring detailed execution in our manufacturing processes. You will collaborate with passionate colleagues to drive our mission and deliver outstanding results.

What will you do?

The Incumbent provides technical support on the manufacture of all the products at the site. Responsible to support all the technical and process activities, validation, qualification activities of products and processes, re-qualification activities and quality investigations. The incumbent will report to the Manager, Technical Operations.

Responsibilities

Support NPI (New Product Introduction) and existing products by participating in validation, qualification activities of products and processes, re-qualification activities, and quality investigations.Author technical operations protocols, reports, and other documentation related to existing products or NPI at the site.Provide training to the Operations team as vital to support manufacturing and process activities.Demonstrate excellent technical writing skills with respect to reports, protocols, quality investigations, and change requests.Provide technical support for day-to-day production activities of commercial products, including identifying root causes of problems, implementing process improvements, and introducing new production technologies.Offer technical mentorship for quality compliance activities, including documentation updates to batch records, SOPs, risk assessments, change control, investigations, and CAPA.Engage in Continuous Process Verification (CPV) and Annual Product Review (APR) activities to trend, monitor, and analyze process parameters, CQAs, and equipment performance, using appropriate statistical tools.Promote EHS safe practices and ensure all activities align with EHS standards and site safety SOPs. Participate in safety activities, HAZOPS, and process safety activities related to the product at the site.

How will you get here?

Education

Bachelor's degree or equivalent experience in engineering, biological/chemical sciences, or related subject areas is required.

Experience

1 to 2 years of Pharmaceutical experience preferred.

Knowledge, Skills, Abilities

Knowledge of GMP.Proficiency in Statistical Process Controls and related tools.Strong computer skills.Understanding of laws and regulations related to safety and environmental conservation.Flexibility and attentiveness.High motivation to work in the pharmaceutical industry.Strong team collaboration skills.