Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials
Job Description
Job Title: Engineer/Scientist II, QC
Discover the opportunity to join our dynamic team at Thermo Fisher Scientific Inc. as an Engineer/Scientist II in Quality Control. This role offers the chance to work in a world-class environment where your contributions will significantly impact the success of our products and services. Join us in our mission to enable our customers to make the world healthier, cleaner, and safer.
Key Responsibilities:
Manage the Environmental Monitoring Program, ensuring flawless execution and compliance.
Coordinate the QC testing of Bioburden to ANSI/AAMI/ISO 11737-1:2018 and QC Sterility to ANSI/AAMI/ISO 11137-2 VDmax.
Conduct and manage validations of test methods and equipment.
Participate in endotoxin and particulate testing of products and manage QC labs related to in-process testing.
Lead performance of in-process, finished product, and raw material testing of Single Use Technologies containers.
Develop and qualify new internal QC testing requirements, strictly following applicable regulatory requirements.
Coordinate all external laboratory testing for Quality Control within the Logan site.
Maintain accurate records of test results and develop testing methods.
Provide education and training to laboratory personnel, ensuring adherence to standard methodologies.
Complete special projects assigned by Quality management, contributing to continuous improvement and excellence.
Minimum Requirements/Qualifications:
High school diploma or equivalent required.
Bachelor's degree or equivalent experience in Biological Sciences.
Minimum of 5 years' experience in biological/pharmaceutical laboratory applications.
Proficiency with MS Office applications and various computer systems/software.
Extensive experience working in a cGMP environment and knowledge of ISO 13485.
Outstanding organizational skills, attention to detail, and problem-solving abilities.
Proven experience in root cause analysis and working knowledge of QMS tools.
Ability to work independently with minimal supervision and collaborate effectively with cross-functional teams.
Physical and Environmental Requirements:
Ability to work in a fast-paced controlled cleanroom environment for up to 8 hours a day.
Specific gowning requirements including gloves, hair and beard net, and face cover.
Capability to use PPE and understand chemical hygiene, including handling common chemicals like disinfectants and solvents.
Must be physically able to stand, move about, and occasionally lift up to 50 pounds unassisted.
Join Thermo Fisher Scientific Inc. and embark on a rewarding career where you can make a difference. Apply today and be part of a team that values integrity, intensity, innovation, and involvement.
