QC Validation Engineer III
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Job Location:
Detroit, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Strong Odors (chemical lubricants biological products etc.)Job Description
Location: Detroit MI. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States withoutsponsorship.
*Must be able to pass a comprehensive background check whichincludes a drug screening.
At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons - with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fast-growing global organization that values passion and unique contributions.
A Day in the Life:
- Ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.
- Lead complex validation projects for laboratory equipment analytical test methods equipment processes utilities and computer systems
- Collaborate with cross-functional teams to maintain cGMP standards.
- Contribute to continuous improvement initiatives support team members providing technical expertise.
- This role offers professional growth opportunities as you help enable life-changing therapies through robust validation strategies and execution.
Minimum Requirements:
Education
- Minimum Required Education: Bachelor of Science (BS) degree in Science or Technical field.
Experience
- 3 years of validation experience in a lab environment
- Manufacturing validation experience is a plus
- Experience leading complex validation projects and coordinating cross-functional teams
- Experience with regulatory inspections and client audits preferred
Knowledge Skills Abilities
- Strong knowledge of cGMP regulations including FDA EMA and ISO requirement
- Experience writing and executing validation protocols including IQ/OQ/PQ documentation
- Expertise in risk assessment methodologies and statistical analysis
- Proficiency with validation of manufacturing equipment utilities cleaning processes and computer systems
- Strong technical writing and documentation skills
- Advanced problem-solving abilities and root cause analysis experience
- Excellent verbal/written communication and interpersonal skills
- Proficiency with relevant software tools (MS Office statistical packages validation systems)
- Knowledge of lean manufacturing and continuous improvement methodologies
- Ability to work in cleanroom environments when required
- Flexibility to work extended hours or alternate shifts based on project needs
- May require travel on as needed basis
Physical Requirements / Work Environment
Work requires standing for long durations managing materials and operating quality inspection instruments in a manufacturing setting.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Apply today!
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
