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Engineer III, Validation
ThermoFisher Scientific • Plainville, MA 02762 • Posted 21 days ago
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In-person • Full-time • Senior Level
Job Highlights
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As a Validation Engineer III at Thermo Fisher Scientific, you will play a critical role in ensuring that quality requirements for products, processes, systems, or equipment are met. This position involves reviewing and approving validation documentation for clinical and commercial drug manufacturing of cell and gene therapy products, crafting Quality Assurance programs, analyzing data from validation tests, and leading teams in developing and modifying procedures to meet required standards. You will work directly with customers to address Quality issues and lead issue resolution.
Responsibilities
- Craft Quality Assurance programs and systems to ensure product quality and compliance with regulatory requirements.
- Analyze data from validation tests to determine if systems and processes meet required criteria and specifications.
- Lead teams in building and modifying procedures to ensure appropriate processes and testing are conducted.
- Evaluate current and new regulations, perform gap analyses, and take appropriate actions to resolve deficiencies.
- Develop short and long-term goals, critical metrics, and objectives to efficiently implement Quality initiatives.
- Analyze trends and team with Validation to investigate, conduct root cause analysis, recommend corrective actions, and analyze data to improve processes and products.
- Work directly with customers to address Quality issues and lead issue resolution.
Qualifications
Required
- Bachelor's degree in mechanical, chemical, biomedical, engineering, or a related field.
- At least 3 years experience in a Quality or Validation function in a regulated environment.
- Direct validation experience is desired.
- Ability to collaborate effectively in multi-functional teams.
- Familiarity with Quality standards such as 21 CFR Part 820 and ISO 13485.
- Knowledge of cGMPs and FDA/Industry expectations.
- Familiarity with a variety of concepts, practices and procedures.
- Strong interpersonal skills and the ability to handle critical matters with tact.
About ThermoFisher Scientific
Thermo Fisher Scientific is a multinational biotechnology company that provides a wide range of products and services in the scientific research and diagnostics industry. They offer scientific instruments, laboratory equipment, diagnostic testing solutions, and more to customers worldwide in industries such as pharmaceuticals, biotechnology, healthcare, academia, and environmental research. Thermo Fisher Scientific is known for its high-quality products, robust R&D capabilities, and strategic acquisitions that have solidified its position as a leader in the market.
Full Job Description
**Work Schedule**
First Shift (Days)
**Environmental Conditions**
Office
**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.
**Location/Division Specific Information**
Plainville, MA -This role will support our Viral Vectors (VVS) Plainville Business Unit.
**Discover Impactful Work:**
At Thermo Fisher Scientific, we offer an exceptional opportunity for a Quality Engineer II to make a significant impact. As a Quality Engineer II, you will play a critical role in ensuring that quality requirements for products, processes, systems, or equipment are fulfilled. Your responsibilities will include reviewing and approving validation documentation for clinical and commercial drug manufacturing of cell and gene therapy products. You will be a key contributor to our world-class Quality System.
**A Day in the Life:**
+ Craft Quality Assurance programs and systems to ensure product quality and compliance with regulatory requirements.
+ Analyze data from validation tests to determine if systems and processes meet required criteria and specifications.
+ Lead teams in building and modifying procedures to ensure appropriate processes and testing are conducted.
+ Evaluate current and new regulations, perform gap analyses, and take appropriate actions to resolve deficiencies.
+ Develop short and long-term goals, critical metrics, and objectives to efficiently implement Quality initiatives.
+ Analyze trends and team with Validation to investigate, conduct root cause analysis, recommend corrective actions, and analyze data to improve processes and products.
+ Work directly with customers to address Quality issues and lead issue resolution.
+ Crafts Quality Assurance programs and systems for product and/or process development, manufacturing, and testing.
+ Analyzes data from validation tests to ensure compliance with regulatory criteria and specifications.
+ Leads teams in developing and modifying procedures to meet required standards.
+ Evaluates regulations, performs gap analyses, and takes appropriate actions to resolve deficiencies.
+ Develops short and long-term goals, critical metrics, and objectives.
+ Analyzes trends, investigates issues, recommends corrective actions, and reviews data to improve processes and products.
**Keys to Success:**
**Education**
+ Bachelor's degree in mechanical, chemical, biomedical, engineering, or a related field required.
**Experience**
+ Requires at least 3 years experience in a Quality or Validation function in a regulated environment.
+ Direct validation experience is desired.
**Knowledge, Skills, Abilities**
+ Ability to collaborate effectively in multi-functional teams.
+ Familiarity with Quality standards such as 21 CFR Part 820 and ISO 13485.
+ Knowledge of cGMPs and FDA/Industry expectations.
+ Familiarity with a variety of concepts, practices and procedures.
+ Strong interpersonal skills and the ability to handle critical matters with tact.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, 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.
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.
First Shift (Days)
**Environmental Conditions**
Office
**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.
**Location/Division Specific Information**
Plainville, MA -This role will support our Viral Vectors (VVS) Plainville Business Unit.
**Discover Impactful Work:**
At Thermo Fisher Scientific, we offer an exceptional opportunity for a Quality Engineer II to make a significant impact. As a Quality Engineer II, you will play a critical role in ensuring that quality requirements for products, processes, systems, or equipment are fulfilled. Your responsibilities will include reviewing and approving validation documentation for clinical and commercial drug manufacturing of cell and gene therapy products. You will be a key contributor to our world-class Quality System.
**A Day in the Life:**
+ Craft Quality Assurance programs and systems to ensure product quality and compliance with regulatory requirements.
+ Analyze data from validation tests to determine if systems and processes meet required criteria and specifications.
+ Lead teams in building and modifying procedures to ensure appropriate processes and testing are conducted.
+ Evaluate current and new regulations, perform gap analyses, and take appropriate actions to resolve deficiencies.
+ Develop short and long-term goals, critical metrics, and objectives to efficiently implement Quality initiatives.
+ Analyze trends and team with Validation to investigate, conduct root cause analysis, recommend corrective actions, and analyze data to improve processes and products.
+ Work directly with customers to address Quality issues and lead issue resolution.
+ Crafts Quality Assurance programs and systems for product and/or process development, manufacturing, and testing.
+ Analyzes data from validation tests to ensure compliance with regulatory criteria and specifications.
+ Leads teams in developing and modifying procedures to meet required standards.
+ Evaluates regulations, performs gap analyses, and takes appropriate actions to resolve deficiencies.
+ Develops short and long-term goals, critical metrics, and objectives.
+ Analyzes trends, investigates issues, recommends corrective actions, and reviews data to improve processes and products.
**Keys to Success:**
**Education**
+ Bachelor's degree in mechanical, chemical, biomedical, engineering, or a related field required.
**Experience**
+ Requires at least 3 years experience in a Quality or Validation function in a regulated environment.
+ Direct validation experience is desired.
**Knowledge, Skills, Abilities**
+ Ability to collaborate effectively in multi-functional teams.
+ Familiarity with Quality standards such as 21 CFR Part 820 and ISO 13485.
+ Knowledge of cGMPs and FDA/Industry expectations.
+ Familiarity with a variety of concepts, practices and procedures.
+ Strong interpersonal skills and the ability to handle critical matters with tact.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, 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.
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.
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