Job Description

Overview

We aim to help customers improve global health and safety. Our 100,000+ team members uphold Integrity, Intensity, Innovation, and Involvement.

Job Title: Engineer III, Manufacturing Engineer in Business
Job Profile Title: Engineer III, Production Engineer
Direct Report To: Manufacturing Engineering Manager
Group/ Division: SUD
Career Band: 6
Position Location: Cramlington
Number of Direct Reports: 0

Join the Manufacturing Engineering team, focusing on improving BPC / Chambers manufacturing equipment and processes. Support the creation and execution of procedures to cGMP Standards, lead engineering projects to meet performance goals, budgets, and timelines. Conduct investigations into validation failures, implement corrective actions, and address technical issues. You may need to visit sister branches internationally to exchange knowledge, comprising under 5% of yearly travel.

Responsibilities

• Support creation and execution of procedures to cGMP standards.
• Lead engineering projects to meet performance goals, budgets, and timelines.
• Conduct investigations into validation failures and implement corrective actions.
• Address technical issues related to manufacturing equipment and processes.
• Collaborate with cross-functional teams to optimize BPC / Chambers manufacturing equipment and processes.
• Possibly travel to sister branches internationally (≤5% of yearly travel).

Qualifications

• Mechanical/Process/Manufacturing Engineering/Science Degree or equivalent experience in engineering or another scientific field; prior practical validation experience involving Factory Acceptance Testing, Site Acceptance Testing, and IQ/OQ protocols.
• Experience in the pharmaceutical sector is beneficial.
• Experience in a regulated industry/environment is essential.
• Experience leading/assisting qualification project executions and close out.
• Self-motivated, proactive, and capable of adhering to project timelines.
• Experience writing, reviewing, and implementing project URS, FAT, IQ/OQ, DoE & PV protocols.
• Proficient understanding of Quality systems in the Pharmaceutical Sector.
• Proficient in Solidworks or AutoCAD.
• Strong attention to detail and ability to identify and remediate issues found during testing.
• Excellent verbal and written communication, including technical authorship.
• Proficient in Microsoft Office (Word, Excel).
• Understanding of cGMP for all required paperwork.

Environment & Benefits

• Work Schedule: Standard (Mon-Fri).
• Environmental Conditions: Able to lift 40 lbs. without assistance; GMP safety standards; cleanroom restrictions (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.); loud noises from equipment/machinery; PPE required (safety glasses, gowning, gloves, lab coat, ear plugs).
• Benefits: Competitive salary, holidays, annual bonuses, private health insurance, life insurance, pension plan. Flexible benefits package.
• Equity statement: 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.